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A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB) (PRESENCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03305809
Recruitment Status : Completed
First Posted : October 10, 2017
Results First Posted : July 23, 2021
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lewy Body Dementia
Interventions Drug: LY3154207
Drug: Placebo
Enrollment 344
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 10 Milligram (mg) LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description Participants received placebo administered orally once a day (QD). Participants received 10 mg LY3154207 administered orally QD. Participants received 30 mg LY3154207 administered orally QD. Participants received 75 mg LY3154207 administered orally QD.
Period Title: Overall Study
Started 86 86 85 87
Received at Least One Dose of Study Drug 86 86 85 87
Completed 79 78 66 60
Not Completed 7 8 19 27
Reason Not Completed
Adverse Event             2             2             6             6
Death             0             0             1             1
Lost to Follow-up             1             2             0             0
Sponsor Decision             1             0             1             8
Physician Decision             0             0             2             4
Progressive Disease             0             0             1             0
Protocol Violation             1             0             2             3
Withdrawal due to Assessment Committee Decision             0             0             0             2
Withdrawal by Subject             2             4             5             2
Withdrawal due to Caregiver Circumstances             0             0             1             1
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207 Total
Hide Arm/Group Description Participants received placebo administered orally QD. Participants received 10 mg LY3154207 administered orally QD. Participants received 30 mg LY3154207 administered orally QD. Participants received 75 mg LY3154207 administered orally QD. Total of all reporting groups
Overall Number of Baseline Participants 86 86 85 87 344
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 86 participants 85 participants 87 participants 344 participants
73.00  (7.02) 72.50  (6.70) 71.90  (7.35) 73.00  (5.21) 72.60  (6.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 85 participants 87 participants 344 participants
Female 16 13 15 15 59
Male 70 73 70 72 285
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 85 participants 87 participants 344 participants
Hispanic or Latino 8 5 9 11 33
Not Hispanic or Latino 77 81 76 75 309
Unknown or Not Reported 1 0 0 1 2
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 85 participants 87 participants 344 participants
American Indian or Alaska Native 1 1 0 0 2
Asian 2 1 1 0 4
Native Hawaiian or Other Pacific Islander 0 0 0 0 0
Black or African American 4 3 2 2 11
White 79 81 81 85 326
More than one race 0 0 1 0 1
Unknown or Not Reported 0 0 0 0 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 86 participants 85 participants 87 participants 344 participants
Canada 3 2 3 2 10
Puerto Rico 5 2 4 4 15
United States 78 82 78 81 319
1.Primary Outcome
Title Change From Baseline in the Continuity of Attention (CoA) Composite Score of the Cognitive Drug Research Computerized Cognition Battery (CDR-CCB)
Hide Description The CDR-CCB tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning which includes tests of attention (simple and choice reaction time, digit vigilance), working memory (spatial and numeric) and episodic memory (word recognition, picture recognition). Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerized battery tests. For continuity of attention, the score range is -999 to 35. A high score reflects someone able to keep his/her mind on a single task for a prolonged period. A negative change from baseline reflects impairment compared to baseline. Data presented are model-based bayesian posterior mean response rates with 95% credible interval.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug, who had the baseline efficacy assessment and had at least 1 postdose efficacy assessment.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 69 74 65 54
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
1.04
(-0.339 to 2.373)
0.15
(-1.206 to 1.496)
0.96
(-0.448 to 2.362)
0.26
(-1.310 to 1.801)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -0.89
Confidence Interval (2-Sided) 95%
-2.776 to 0.969
Estimation Comments Analyses were conducted using a bayesian mixed-model repeated measures (MMRM), and posterior mean change difference is reported.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-1.996 to 1.879
Estimation Comments Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Posterior Mean Difference
Estimated Value -0.78
Confidence Interval (2-Sided) 95%
-2.873 to 1.277
Estimation Comments Analyses were conducted using a bayesian MMRM, and posterior mean change difference is reported.
2.Secondary Outcome
Title Change From Baseline on the Alzheimer's Disease Cooperative Study-Clinician Global Impression of Change (ADCS-CGIC) Score
Hide Description The ADCS-CGIC is a validated categorical measure of change in a participant's clinical condition between baseline and follow-up visits; it is used to assess global clinical status. The ADCS CGIC score is based on direct examination of the participant and an interview of the caregiver. The rater should refer to the baseline ADCS-CGIC worksheets in making a rating. A skilled and experienced clinician who is blinded to treatment assignment rates the participant on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). 1= Very much better 2= Much better 3= A little better 4= Same 5= A little worse 6= Much worse 7= Very much worse. Least squares (LS) means were calculated using mixed model repeated measures adjusting for treatment + visit + treatment*visit + age*acheifl + age + concomitant use of acetylcholinesterase inhibitor (AChEI).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline CGIC data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 73 77 69 55
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
4.0  (0.13) 3.8  (0.12) 3.3  (0.13) 3.1  (0.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.273
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.54 to 0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.02 to -0.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-1.29 to -0.53
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline on the CDR-CCB Power of Attention (PoA) Composite Score
Hide Description The PoA is a composite score derived from the CDR-CCB that measures the intensity of concentration (ability to focus attention): the faster the responses, the more processes are being brought to bear upon the task. Power of attention is calculated from the sum of three cognitive function speed tests: simple reaction time, choice reaction time and the speed of detections in digit vigilance task. Score ranges from 450 milliseconds - 61500 milliseconds. A low score reflects a fast reaction time and a high intensity of concentration. A positive change from baseline reflects impairment compared to the baseline assessment Values are calculated by a computer and higher scores mean better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline CDR-CCB PoA data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 69 73 65 54
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
64.14  (48.681) -6.57  (48.396) -42.88  (49.804) -59.58  (54.379)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.303
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -70.71
Confidence Interval (2-Sided) 95%
-205.53 to 64.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 68.495
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.125
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -107.02
Confidence Interval (2-Sided) 95%
-244.09 to 30.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 69.647
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -123.72
Confidence Interval (2-Sided) 95%
-267.18 to 19.74
Parameter Dispersion
Type: Standard Error of the Mean
Value: 72.892
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)
Hide Description The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS--Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline ADAS-Cog13 data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 68 73 67 54
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.71  (0.707) -1.11  (0.691) -1.42  (0.720) -1.59  (0.799)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.686
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-2.34 to 1.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.985
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.485
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-2.70 to 1.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.011
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.406
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.89
Confidence Interval (2-Sided) 95%
-2.98 to 1.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.064
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Screening in the Montreal Cognitive Assessment (MoCA) Score
Hide Description The Montreal Cognitive Assessment is a screening tool for global cognitive function with a total score ranging from 0 to 30 units on a scale. The MoCA is divided into 7 subscores (maximum possible subscore): visuospatial/executive (5 points), naming (3 points), memory (5 points for delayed recall), attention (6 points), language (3 points), abstraction (2 points) and orientation to time and place (6 points). A score of 26-30 is normal. A score less than 26 is considered as mild cognitive impairment. Higher values represent a better outcome. LS means were calculated using mixed model repeated measures adjusting for baseline total Score + treatment + visit + treatment*Visit + visit*baseline total Score + age + concomitant use of AChEI.
Time Frame Screening (Baseline), Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline MoCA data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 71 76 68 55
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.90  (0.432) 1.34  (0.423) 1.12  (0.448) 1.84  (0.496)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.464
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.44
Confidence Interval (2-Sided) 95%
-0.74 to 1.63
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.603
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.720
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-1.00 to 1.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.623
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
-0.34 to 2.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.655
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score and Individual Item Scores
Hide Description The NPI is a condition-specific measure designed to assess neuropsychiatric disturbances in people with Alzheimer Disease (AD),as well as other related dementing disorders.It assesses 12 behavioral disturbances,namely delusions,hallucinations,depression/dysphoria,anxiety,agitation/aggression,elation/euphoria,disinhibition,irritability/lability,apathy, aberrant motor activity, night-time behavior disturbances,and appetite/eating abnormalities.The frequency scored from 0 (never) to 4 (very frequently).The Severity scored from 0 (none) to 3 (marked).The domain score is obtained by multiplying frequency and severity scores.The total NPI score is sum total of all of individual domain scores (0-144).Higher score indiciates more abnormal behaviors.LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline NPI score data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 73 77 66 55
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Total Score Number Analyzed 73 participants 77 participants 65 participants 55 participants
-1.62  (0.868) -2.24  (0.852) -3.32  (0.920) -2.37  (1.005)
Delusions Number Analyzed 73 participants 77 participants 66 participants 54 participants
0.13  (0.124) -0.04  (0.121) -0.25  (0.130) 0.02  (0.144)
Hallucinations Number Analyzed 73 participants 77 participants 66 participants 55 participants
-0.09  (0.131) -0.11  (0.128) -0.44  (0.137) -0.38  (0.151)
Agitation/Aggression Number Analyzed 71 participants 77 participants 66 participants 55 participants
0.04  (0.130) -0.06  (0.126) -0.02  (0.135) -0.20  (0.148)
Depression/Dysphoria Number Analyzed 73 participants 77 participants 66 participants 55 participants
-0.22  (0.155) -0.16  (0.151) -0.33  (0.164) -0.35  (0.179)
Anxiety Number Analyzed 73 participants 77 participants 65 participants 55 participants
-0.15  (0.141) -0.15  (0.138) 0.07  (0.149) -0.22  (0.163)
Elation/Euphoria Number Analyzed 73 participants 77 participants 65 participants 55 participants
0.14  (0.069) 0.03  (0.068) 0.00  (0.074) 0.06  (0.080)
Apathy/Indifference Number Analyzed 73 participants 77 participants 65 participants 55 participants
-0.36  (0.191) -0.81  (0.186) -0.68  (0.202) -0.55  (0.220)
Disinhibition Number Analyzed 73 participants 77 participants 65 participants 55 participants
-0.13  (0.082) -0.11  (0.080) 0.21  (0.087) -0.09  (0.095)
Irritability/Lability Number Analyzed 73 participants 77 participants 65 participants 55 participants
-0.19  (0.130) -0.43  (0.127) -0.25  (0.137) 0.02  (0.150)
Aberrant Motor Behavior Number Analyzed 73 participants 77 participants 65 participants 55 participants
-0.13  (0.106) 0.03  (0.103) -0.23  (0.112) -0.09  (0.122)
Sleep/Nighttime Behavior Disorders Number Analyzed 73 participants 77 participants 66 participants 55 participants
-0.19  (0.287) 0.00  (0.278) -0.58  (0.302) -0.30  (0.329)
Appetite/Eating Disorders Number Analyzed 73 participants 77 participants 66 participants 55 participants
-0.37  (0.270) -0.47  (0.263) -0.80  (0.284) -0.27  (0.311)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Total Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.607
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.62
Confidence Interval (2-Sided) 95%
-3.01 to 1.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.213
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Total Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.180
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.70
Confidence Interval (2-Sided) 95%
-4.19 to 0.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.265
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Total Score
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.572
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-3.36 to 1.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.325
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Delusions
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.320
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.51 to 0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.173
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Delusions
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-0.73 to -0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.180
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Delusions
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.558
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.49 to 0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.190
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Hallucinations
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.924
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.38 to 0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.182
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Hallucinations
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.73 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.189
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Hallucinations
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.148
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.68 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.199
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Agitation/Aggression
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.552
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.46 to 0.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.180
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Agitation/Aggression
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.735
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.43 to 0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.188
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Agitation/Aggression
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.224
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.63 to 0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.197
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Depression/Dysphoria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.783
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.06
Confidence Interval (2-Sided) 95%
-0.37 to 0.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.216
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Depression/Dysphoria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.640
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.55 to 0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.226
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Depression/Dysphoria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.592
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.59 to 0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.236
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Anxiety
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.993
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.39 to 0.39
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.197
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Anxiety
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.290
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-0.19 to 0.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.205
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Anxiety
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.722
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.50 to 0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.215
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Elation/Euphoria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.246
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.30 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.097
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Elation/Euphoria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.34 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.101
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Elation/Euphoria
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.482
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.28 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.106
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Apathy/Indifference
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.97 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.266
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Apathy/Indifference
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.248
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.87 to 0.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.278
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Apathy/Indifference
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.516
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.76 to 0.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.290
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Disinhibition
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.875
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.21 to 0.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.114
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Disinhibition
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
0.10 to 0.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.119
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Disinhibition
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.761
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.21 to 0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.125
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Irritability/Lability
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.183
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.60 to 0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.181
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Irritability/Lability
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.765
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.43 to 0.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.189
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Irritability/Lability
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.279
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.21
Confidence Interval (2-Sided) 95%
-0.18 to 0.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.198
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Aberrant Motor Behavior
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.252
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.12 to 0.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.147
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Aberrant Motor Behavior
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.526
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.40 to 0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.154
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Aberrant Motor Behavior
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.800
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.28 to 0.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.161
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Sleep/Nighttime Behavior Disorders
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.623
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-0.59 to 0.98
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.400
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Sleep/Nighttime Behavior Disorders
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.354
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-1.21 to 0.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.418
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Sleep/Nighttime Behavior Disorders
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.809
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.97 to 0.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.437
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Appetite/Eating Disorders
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.790
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.10
Confidence Interval (2-Sided) 95%
-0.84 to 0.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.376
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Appetite/Eating Disorders
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.280
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-1.20 to 0.35
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.392
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Appetite/Eating Disorders
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.797
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.11
Confidence Interval (2-Sided) 95%
-0.70 to 0.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.412
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the Epworth Sleepiness Scale (ESS) Score
Hide Description The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline ESS data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 73 77 67 55
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.33  (0.437) -1.04  (0.426) -1.21  (0.452) -1.92  (0.500)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.71
Confidence Interval (2-Sided) 95%
-1.91 to 0.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.610
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-2.12 to 0.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.631
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.59
Confidence Interval (2-Sided) 95%
-2.90 to -0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.663
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Movement Disorder Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score (Sum of Parts I-III)
Hide Description Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for MDS-UPDRS MDS-UPDRS Part I (non-motor experiences of daily living) and Part II (motor experiences of daily living) scores, total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + levodopa equivalency dose (LED).
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline MDS-UPDRS data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 56 70 61 50
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.18  (2.112) -6.58  (1.941) -7.56  (2.084) -10.77  (2.287)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -6.41
Confidence Interval (2-Sided) 95%
-12.04 to -0.77
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.860
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.39
Confidence Interval (2-Sided) 95%
-13.24 to -1.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.969
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -10.60
Confidence Interval (2-Sided) 95%
-16.72 to -4.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.104
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in the Penn Parkinson's Daily Activities Questionnaire-15 (PDAQ-15) Total Score
Hide Description The PDAQ-15 is a 15-item measure of instrumental activities of daily living (IADL) that are impacted by cognitive impairment in participants with parkinson's disease dementia (PDD). The PDAQ-15 is derived from the original 50-item scale, which has demonstrated test-retest reliability, construct validity, sensitivity, and specificity to Parkinson's disease (PD) cognitive impairment and the questionnaire is completed by the caregiver. The score range is 0 to 60, with higher scores indicating better function. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline PDAQ-15 data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 73 77 67 55
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.32  (0.976) 0.23  (0.961) 2.09  (1.018) 1.24  (1.128)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.683
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
-2.13 to 3.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.362
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.41
Confidence Interval (2-Sided) 95%
-0.37 to 5.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.413
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.294
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
-1.37 to 4.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.489
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test Score
Hide Description The DKEFS verbal fluency category switching test measures letter fluency, category fluency, and category switching. The score is the total number of correct words generated during each of the 60-second trials within the three conditions of the test. Scales scores vary from 0 min to N/A max (no concrete maximum). Higher score = higher ability in language processing. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline D-KEFS data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 71 76 66 53
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-0.19  (0.280) 0.44  (0.271) 0.88  (0.292) 0.30  (0.325)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
-0.13 to 1.40
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.389
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.27 to 1.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.406
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.253
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
-0.35 to 1.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.428
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change in MDS-UPDRS Parts II (Motor Experiences of Daily Living) and III (Motor Exam) From Baseline to Week 12
Hide Description Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. The scale range for Part II total score was 0-52, with higher scores reflecting greater severity. For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity. LS means were calculated using mixed model repeated measures adjusting for baseline total score + treatment + visit + treatment*visit + visit*baseline total score + age + concomitant use of AChEI + LED dose.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline MDS-UPDRS data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 75 77 69 54
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Motor Experiences of Daily Living Number Analyzed 73 participants 77 participants 69 participants 53 participants
0.28  (0.656) -1.45  (0.649) -2.08  (0.700) -3.22  (0.779)
Motor Exam Number Analyzed 57 participants 71 participants 61 participants 52 participants
-0.12  (1.343) -3.39  (1.240) -3.40  (1.331) -4.35  (1.434)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Motor Experiences of Daily Living
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.061
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.74
Confidence Interval (2-Sided) 95%
-3.56 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.923
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Motor Experiences of Daily Living
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.37
Confidence Interval (2-Sided) 95%
-4.26 to -0.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.960
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Motor Experiences of Daily Living
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.50
Confidence Interval (2-Sided) 95%
-5.50 to -1.51
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.013
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Motor Exam
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.074
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.27
Confidence Interval (2-Sided) 95%
-6.86 to 0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.822
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Motor Exam
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.27
Confidence Interval (2-Sided) 95%
-7.00 to 0.45
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.891
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Motor Exam
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.23
Confidence Interval (2-Sided) 95%
-8.09 to -0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.959
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants Who Met the Potentially Clinically Significant Vital Signs Criteria at 3 Consecutive Time Points at Visit 3
Hide Description Number of participants who met the potentially clinically significant vital signs criteria at 3 consecutive time points at visit 3 were reported. In the event of an unacceptable rate of participants meeting day 1 stopping rules at other doses, adjustments to doses may be made for subsequently randomized participants at the discretion of the internal assessment committee (IAC).
Time Frame Visit 3 (Day 1 stopping rules)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 86 86 65 87
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 1 1
13.Secondary Outcome
Title Change From Baseline in Clinic Blood Pressure (BP) to 8 Hours Post Dose
Hide Description Systolic and diastolic blood pressure obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame Baseline, 8 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline BP data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 81 82 79 85
Least Squares Mean (Standard Error)
Unit of Measure: millimeter of mercury (mmHg)
Sitting Systolic Blood Pressure 9.8  (1.90) 10.1  (1.89) 10.4  (1.92) 19.2  (1.87)
Sitting Diastolic Blood Pressure 4.6  (0.99) 4.9  (0.98) 5.5  (1.00) 8.1  (0.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Sitting Systolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.898
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-4.92 to 5.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Sitting Systolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.821
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-4.71 to 5.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Sitting Systolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 9.4
Confidence Interval (2-Sided) 95%
4.11 to 14.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Sitting Diastolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.805
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-2.40 to 3.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Sitting Diastolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.513
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-1.85 to 3.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Sitting Diastolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
0.83 to 6.28
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Pulse Rate to 8 Hours Post Dose
Hide Description Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame Baseline, 8 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline pulse rate data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 81 82 79 85
Least Squares Mean (Standard Error)
Unit of Measure: beats/min
-2.2  (0.94) 0.2  (0.95) 1.3  (0.95) 6.4  (0.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.5
Confidence Interval (2-Sided) 95%
-0.16 to 5.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
0.93 to 6.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.7
Confidence Interval (2-Sided) 95%
6.06 to 11.27
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline In-clinic BP to Week 12
Hide Description Systolic blood pressure (SBP) and diastolic blood pressure (DBP) obtained from ambulatory blood pressure monitoring (ABPM) was evaluated. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline BP data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 74 77 65 56
Least Squares Mean (Standard Error)
Unit of Measure: millimeters of mercury (mmHg)
Sitting Systolic Blood Pressure -1.2  (1.22) 0.5  (1.19) 0.1  (1.29) 3.0  (1.38)
Sitting Diastolic Blood Pressure -0.9  (0.71) -1.0  (0.70) -0.2  (0.75) 0.3  (0.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Sitting Systolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.339
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.6
Confidence Interval (2-Sided) 95%
-1.72 to 4.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Sitting Systolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.486
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.2
Confidence Interval (2-Sided) 95%
-2.26 to 4.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Sitting Systolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
0.56 to 7.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Sitting Diastolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.935
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-2.04 to 1.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Sitting Diastolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.505
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-1.34 to 2.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Sitting Diastolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.266
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
-0.91 to 3.30
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Pulse Rate to Week 12
Hide Description Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to 8 hours and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline pulse rate data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 74 77 65 56
Least Squares Mean (Standard Error)
Unit of Measure: beats/min
-0.2  (0.67) 0.3  (0.66) 1.5  (0.71) 2.6  (0.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.550
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-1.28 to 2.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
-0.14 to 3.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
0.89 to 4.83
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change in Home Blood Pressure Measurement (HBPM), for SBP, DBP From Baseline to Week 12
Hide Description Systolic and diastolic blood pressure obtained from ABPM was evaluated. Participants followed a standardized measurement protocol for home blood pressure measurement, involving three consecutive measurements, taken one minute apart after a five-minute seated resting period. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline BP data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 48 51 41 41
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
Sitting Systolic Blood Pressure -1.1  (2.52) -8.2  (2.40) 2.0  (2.58) -2.2  (2.62)
Sitting Diastolic Blood Pressure 1.5  (1.50) -2.8  (1.45) 1.0  (1.55) -0.8  (1.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Sitting Systolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.0
Confidence Interval (2-Sided) 95%
-13.92 to -0.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Sitting Systolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.390
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.1
Confidence Interval (2-Sided) 95%
-4.05 to 10.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Sitting Systolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.768
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-8.32 to 6.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Sitting Diastolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.3
Confidence Interval (2-Sided) 95%
-8.48 to -0.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Sitting Diastolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.802
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-4.81 to 3.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Sitting Diastolic Blood Pressure
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.284
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.4
Confidence Interval (2-Sided) 95%
-6.67 to 1.97
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change in HBPM for Pulse Rate From Baseline to Week 12
Hide Description Pulse rate obtained from ABPM was evaluated. Pulse rate measurements will occur at time 0 and every 60 minutes thereafter up to week 12 and pulse rate measurements will be done in the seated position only. LS means were calculated using mixed model repeated measures adjusting for baseline + treatment + visit + visit*baseline + treatment*visit.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline pulse rate data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
Hide Arm/Group Description:
Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 48 51 41 41
Least Squares Mean (Standard Error)
Unit of Measure: beats/min
1.4  (1.52) 1.4  (1.47) 0.7  (1.59) 0.8  (1.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.996
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-4.17 to 4.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.767
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-4.99 to 3.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.791
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-4.96 to 3.79
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in the Physician Withdrawal Checklist (PWC)-20 Total Score From Week 12 to In-Clinic Follow-up Visit
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The Penn PWC-20 is a 20-item checklist originally developed to assess the severity of withdrawal symptoms in anxiolytic medication discontinuation. To determine a change in the Intensity of Discontinuation symptoms, the PWC-20 administered by a trained clinician/rater to assess the intensity of discontinuation symptoms. The assessment has 20 items evaluated to detect withdrawal symptoms. Symptoms are rated on a scale of 0-3.

0. Not present

  1. Mild
  2. Moderate
  3. Severe Total scores range from 0 to 60 with higher scores indicating more severe symptoms.Least squares (LS) means were calculated using mixed model analysis of covariance (ANCOVA) adjusting for predose, sequence, period, day, time, treatment, and treatment*time as fixed effects and participant within sequence and treatment as random effect.
Time Frame Week 12, Follow-up (2 Weeks after Week 12)
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All randomized participants who received at least one dose of study drug with baseline and post-baseline PWC-20 data.
Arm/Group Title Placebo 10 mg LY3154207 30 mg LY3154207 75 mg LY3154207
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Participants received placebo administered orally QD.
Participants received 10 mg LY3154207 administered orally QD.
Participants received 30 mg LY3154207 administered orally QD.
Participants received 75 mg LY3154207 administered orally QD.
Overall Number of Participants Analyzed 35 33 32 24
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Week 12 -1.51  (0.670) -0.53  (0.690) -0.47  (0.701) 0.05  (0.811)
Follow-up -1.27  (0.844) 0.12  (0.877) 0.13  (0.904) 3.32  (1.040)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, 10 mg LY3154207
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.312
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
-0.93 to 2.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, 30 mg LY3154207
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.289
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
-0.89 to 2.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, 75 mg LY3154207
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.141
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.56
Confidence Interval (2-Sided) 95%
-0.53 to 3.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 10 mg LY3154207, 30 mg LY3154207
Comments Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.954
Comments