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An Efficacy and Safety Study of Atabecestat in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia (EARLY)

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: NCT02569398
Recruitment Status : Terminated (Change in benefit-risk profile for individuals with early sporadic Alzheimer Disease because of elevations in liver enzymes in subjects receiving atabecestat)
First Posted : October 6, 2015
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asymptomatic Amyloid-positive
Interventions Drug: Atabecestat, 5 mg
Drug: Atabecestat, 25 mg
Drug: Placebo
Enrollment 557
Recruitment Details  
Pre-assignment Details Total of 557 participants were enrolled in study. Study was early terminated based on experience of significant elevations in liver enzymes in participants receiving JNJ-54861911 in this study and 54861911ALZ2004 (NCT02406027).
Arm/Group Title Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg)
Hide Arm/Group Description Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months. Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016). Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
Period Title: Overall Study
Started 185 189 183
Completed 0 0 0
Not Completed 185 189 183
Reason Not Completed
Adverse Event             0             1             6
Withdrawal by Subject             43             43             30
Study terminated by sponsor             130             131             134
Other             12             14             13
Arm/Group Title Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg) Total
Hide Arm/Group Description Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months. Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016). Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months. Total of all reporting groups
Overall Number of Baseline Participants 185 189 183 557
Hide Baseline Analysis Population Description
Intent-to-treat analysis set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 185 participants 189 participants 183 participants 557 participants
70.2  (5.81) 70.6  (5.26) 70.5  (5.62) 70.4  (5.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 189 participants 183 participants 557 participants
Female
108
  58.4%
116
  61.4%
117
  63.9%
341
  61.2%
Male
77
  41.6%
73
  38.6%
66
  36.1%
216
  38.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 189 participants 183 participants 557 participants
Hispanic or Latino
8
   4.3%
6
   3.2%
7
   3.8%
21
   3.8%
Not Hispanic or Latino
176
  95.1%
183
  96.8%
176
  96.2%
535
  96.1%
Unknown or Not Reported
1
   0.5%
0
   0.0%
0
   0.0%
1
   0.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 185 participants 189 participants 183 participants 557 participants
Asian
12
   6.5%
11
   5.8%
11
   6.0%
34
   6.1%
Black or African American
2
   1.1%
1
   0.5%
2
   1.1%
5
   0.9%
Hispanic or Latino
4
   2.2%
3
   1.6%
5
   2.7%
12
   2.2%
Other
5
   2.7%
4
   2.1%
2
   1.1%
11
   2.0%
White Non-Hispanic
162
  87.6%
170
  89.9%
163
  89.1%
495
  88.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 185 participants 189 participants 183 participants 557 participants
AUSTRALIA
21
  11.4%
21
  11.1%
21
  11.5%
63
  11.3%
BELGIUM
9
   4.9%
10
   5.3%
9
   4.9%
28
   5.0%
CANADA
2
   1.1%
2
   1.1%
3
   1.6%
7
   1.3%
DENMARK
20
  10.8%
20
  10.6%
20
  10.9%
60
  10.8%
FINLAND
2
   1.1%
2
   1.1%
3
   1.6%
7
   1.3%
GERMANY
2
   1.1%
3
   1.6%
3
   1.6%
8
   1.4%
ITALY
2
   1.1%
2
   1.1%
1
   0.5%
5
   0.9%
JAPAN
11
   5.9%
11
   5.8%
11
   6.0%
33
   5.9%
MEXICO
4
   2.2%
3
   1.6%
2
   1.1%
9
   1.6%
NETHERLANDS
10
   5.4%
11
   5.8%
10
   5.5%
31
   5.6%
SPAIN
9
   4.9%
10
   5.3%
9
   4.9%
28
   5.0%
SWEDEN
3
   1.6%
5
   2.6%
4
   2.2%
12
   2.2%
UNITED KINGDOM
23
  12.4%
22
  11.6%
22
  12.0%
67
  12.0%
UNITED STATES
67
  36.2%
67
  35.4%
65
  35.5%
199
  35.7%
1.Primary Outcome
Title Change From Baseline in Preclinical Alzheimer Cognitive Composite (PACC) Score at Endpoint (Month 24)
Hide Description PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-48 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: (ranges 0 [none]-135 [best performance]) and Mini Mental State Examination (Range 0 [worst] - 30 [best performance]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.
Time Frame Baseline and Endpoint (Month 24)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) analysis set (all randomized participants) with participants in whom PACC change score is non-missing at greater than or equal to (>=) 1 post-baseline time point.
Arm/Group Title Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg)
Hide Arm/Group Description:
Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months.
Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
Overall Number of Participants Analyzed 74 73 64
Mean (Standard Deviation)
Unit of Measure: z-score
0.096  (1.7261) -0.417  (1.8372) -1.096  (1.7796)
2.Secondary Outcome
Title Change From Baseline in Cognitive Function Index (CFI) Score at Endpoint (Month 24)
Hide Description The CFI is a modified version of the Mail-in Cognitive Function Screening Instrument, a participant- and informant-reported outcome measure developed by the Alzheimer's Disease Cooperative Study (ADCS). This assessment includes 15 questions (14 of which contribute to the total score, and 1 additional unscored item) that assess the participant's perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. Study participants and their informants independently rate the participant's abilities. A participant-reported and an informant-reported total score is calculated which ranges from 0 to 14 (yes=1; no=0; maybe=0.5 for each question) with higher scores indicating greater impairment.
Time Frame Baseline and Endpoint (Month 24)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all randomized participants. Here 'N' (number of Participants Analyzed) indicates the number of participants analyzed at this outcome measure and 'n' (number analyzed) was defined as the number of participants evaluable at specified category.
Arm/Group Title Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg)
Hide Arm/Group Description:
Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months.
Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
Overall Number of Participants Analyzed 28 27 26
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Total CFI Participant score Number Analyzed 28 participants 27 participants 26 participants
-0.04  (1.866) 0.09  (1.135) 0.75  (2.628)
Total CFI Informant score Number Analyzed 27 participants 27 participants 26 participants
-0.22  (1.660) 0.30  (1.469) 0.88  (2.475)
3.Secondary Outcome
Title Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Prevention Instrument (ADCS-ADLPI) Total Score at Endpoint (Month 24)
Hide Description The Alzheimer's Disease Cooperative Study - Activities of Daily Living -Prevention Instrument (ADCS-ADLPI) is a functional measure composed of 18 items that includes 15 activities of daily living rated on a 4-point scale and 3 high level function items. Study participants and their informants independently rate the participant's level of ability (with no difficulty = 3, with some difficulty = 2, with a lot of difficulty = 1, did not do/don't know = 0). Informants are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if any errors were made performing the task. High-level function items are rated as "yes" or "no". The scores range from 0 to 45 with higher scores indicating less impairment. The total score is the sum of the scores of the 15 activities of daily living questions (range: 0-45) with higher scores indicating less impairment.
Time Frame Baseline and Endpoint (Month 24)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all randomized participants. Here 'n' (number analyzed) was defined as the number of participants evaluable at specified category.
Arm/Group Title Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg)
Hide Arm/Group Description:
Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months.
Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
Overall Number of Participants Analyzed 185 189 183
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Total ADL Participant score Number Analyzed 124 participants 117 participants 110 participants
-0.04  (2.975) 0.35  (2.832) 0.15  (2.834)
Total ADL Informant score Number Analyzed 122 participants 115 participants 109 participants
0.26  (4.223) -0.12  (3.941) 0.24  (4.085)
4.Secondary Outcome
Title Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score at Endpoint (Month 24)
Hide Description RBANS is 20 to 25 minute battery developed for cognitive assessment, detection, and characterization of dementia. RBANS includes 12 subtests that measure following 5 indices: (1)Attention Index, composed of Digit Span and Coding; (2)Language Index, consisting of Picture Naming and Semantic Fluency subtests; (3)Visuospatial/Construction Index, made up of Figure Copy and Line Orientation subtests; (4)Immediate Memory Index, composed of List Learning and Story Memory subtests, and (5)Delayed Memory Index, consisting of List Recall, List Recognition, Story Recall, and Figure Recall subtests. Completion of RBANS yields 5 index scores based on participant performance on various subtests, as well as a composite Total Index score for battery. Total index scores range from 40 to 160, and are normalized to a mean of 100 and standard deviation (SD) of 15. Higher scores indicate less impairment.
Time Frame Baseline and Endpoint (Month 24)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all randomized participants. Here 'N' (Number of participants analyzed) was defined as the number of participants evaluable at this outcome measure.
Arm/Group Title Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg)
Hide Arm/Group Description:
Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months.
Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
Overall Number of Participants Analyzed 124 121 114
Mean (Standard Deviation)
Unit of Measure: Score on a scale
2.0  (8.90) -0.9  (7.79) -1.7  (9.75)
5.Secondary Outcome
Title Change From Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score at Endpoint (Month 24)
Hide Description The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18. Higher score indicates severe impairment.
Time Frame Baseline and Endpoint (Month 24)
Hide Outcome Measure Data
Hide Analysis Population Description
As the study was terminated early with lesser participants and lesser sample size, data for this endpoint was not collected and analyzed per change in planned analysis.
Arm/Group Title Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg)
Hide Arm/Group Description:
Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months.
Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change From Baseline in Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score at Endpoint (Month 24)
Hide Description The Neuropsychological Assessment Battery Daily Living Tests (NABDLTs) Score represent a series of performance based measures covering 5 domains (Attention, Memory, Language, Spatial, and Executive function). These are valid, clinically meaningful measures that objectively assess functional deficits. Participant performance scores on NAB subtests are summed, and then normalized to yield an index score. Index scores can range from less than or equal to (< =) 55 to greater than or equal to (> =) 145, and are normalized to a mean of 100 and standard deviation of 15. Higher scores indicate less impairment.
Time Frame Baseline and Endpoint (Month 24)
Hide Outcome Measure Data
Hide Analysis Population Description
As the study was terminated early with lesser participants and lesser sample size, data for this endpoint was not collected and analyzed per change in planned analysis.
Arm/Group Title Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg)
Hide Arm/Group Description:
Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months.
Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016).
Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 24 months
Adverse Event Reporting Description Safety analysis set included all randomized participants who have received at least one study medication.
 
Arm/Group Title Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg)
Hide Arm/Group Description Participants received a single dose of JNJ-54861911 matching placebo tablet orally once daily for up to 24 months. Participants received a single dose of JNJ-54861911 5 milligram (mg) tablet orally once daily for up to 24 months (participants randomized to this group received JNJ-54861911 10 mg prior to protocol amendment 3 and continued to receive JNJ-54861911 5-mg tablets after implementation of protocol Amendment 3; dated: 02-Mar-2016). Participants received a single dose of JNJ-54861911 25 mg tablet orally once daily for up to 24 months.
All-Cause Mortality
Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/185 (0.00%)   0/189 (0.00%)   0/183 (0.00%) 
Hide Serious Adverse Events
Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/185 (4.86%)   18/189 (9.52%)   26/183 (14.21%) 
Cardiac disorders       
Angina Unstable * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Myocardial Infarction * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Tachyarrhythmia * 1  1/185 (0.54%)  0/189 (0.00%)  0/183 (0.00%) 
Eye disorders       
Cataract * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Retinal Detachment * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Gastrointestinal disorders       
Mechanical Ileus * 1  1/185 (0.54%)  0/189 (0.00%)  0/183 (0.00%) 
Hepatobiliary disorders       
Cholangitis * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Cholelithiasis * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Drug-Induced Liver Injury * 1  0/185 (0.00%)  0/189 (0.00%)  3/183 (1.64%) 
Immune system disorders       
Drug Hypersensitivity * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Infections and infestations       
Appendicitis * 1  1/185 (0.54%)  0/189 (0.00%)  0/183 (0.00%) 
Pneumonia * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Poliomyelitis * 1  1/185 (0.54%)  0/189 (0.00%)  0/183 (0.00%) 
Injury, poisoning and procedural complications       
Ankle Fracture * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Facial Bones Fracture * 1  1/185 (0.54%)  0/189 (0.00%)  0/183 (0.00%) 
Femoral Neck Fracture * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Fractured Ischium * 1  1/185 (0.54%)  0/189 (0.00%)  0/183 (0.00%) 
Post Lumbar Puncture Syndrome * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Rib Fracture * 1  1/185 (0.54%)  0/189 (0.00%)  0/183 (0.00%) 
Investigations       
Alanine Aminotransferase Increased * 1  0/185 (0.00%)  0/189 (0.00%)  2/183 (1.09%) 
Aspartate Aminotransferase Increased * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Hepatic Enzyme Increased * 1  0/185 (0.00%)  2/189 (1.06%)  3/183 (1.64%) 
Transaminases Increased * 1  0/185 (0.00%)  1/189 (0.53%)  2/183 (1.09%) 
Metabolism and nutrition disorders       
Dehydration * 1  1/185 (0.54%)  0/189 (0.00%)  0/183 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back Pain * 1  1/185 (0.54%)  1/189 (0.53%)  0/183 (0.00%) 
Osteoarthritis * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adenocarcinoma of Colon * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Benign Ovarian Tumour * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Bladder Cancer * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Breast Cancer Metastatic * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Chronic Lymphocytic Leukaemia * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Gastrointestinal Stromal Tumour * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Invasive Ductal Breast Carcinoma * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Malignant Melanoma * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Prostate Cancer * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Nervous system disorders       
Cerebrovascular Accident * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Cervical Radiculopathy * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Lumbosacral Radiculopathy * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Paraesthesia * 1  1/185 (0.54%)  0/189 (0.00%)  0/183 (0.00%) 
Paralysis Recurrent Laryngeal Nerve * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Transient Ischaemic Attack * 1  1/185 (0.54%)  0/189 (0.00%)  0/183 (0.00%) 
Psychiatric disorders       
Loss of Libido * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Mental Status Changes * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Renal and urinary disorders       
Acute Kidney Injury * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Reproductive system and breast disorders       
Benign Prostatic Hyperplasia * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Ejaculation Failure * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Erectile Dysfunction * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Asthmatic Crisis * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Bronchiectasis * 1  0/185 (0.00%)  0/189 (0.00%)  1/183 (0.55%) 
Emphysema * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
Pulmonary Mass * 1  0/185 (0.00%)  1/189 (0.53%)  0/183 (0.00%) 
1
Term from vocabulary, MedDRA Version 21.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo JNJ-54861911 (5 mg) JNJ-54861911 (25 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   80/185 (43.24%)   75/189 (39.68%)   88/183 (48.09%) 
Gastrointestinal disorders       
Diarrhoea * 1  7/185 (3.78%)  15/189 (7.94%)  28/183 (15.30%) 
General disorders       
Fatigue * 1  3/185 (1.62%)  5/189 (2.65%)  11/183 (6.01%) 
Infections and infestations       
Nasopharyngitis * 1  27/185 (14.59%)  19/189 (10.05%)  16/183 (8.74%) 
Upper Respiratory Tract Infection * 1  19/185 (10.27%)  14/189 (7.41%)  12/183 (6.56%) 
Urinary Tract Infection * 1  7/185 (3.78%)  8/189 (4.23%)  15/183 (8.20%) 
Investigations       
Alanine Aminotransferase Increased * 1  9/185 (4.86%)  9/189 (4.76%)  14/183 (7.65%) 
Aspartate Aminotransferase Increased * 1  8/185 (4.32%)  9/189 (4.76%)  12/183 (6.56%) 
Musculoskeletal and connective tissue disorders       
Back Pain * 1  9/185 (4.86%)  11/189 (5.82%)  10/183 (5.46%) 
Nervous system disorders       
Headache * 1  14/185 (7.57%)  12/189 (6.35%)  16/183 (8.74%) 
Psychiatric disorders       
Abnormal Dreams * 1  1/185 (0.54%)  4/189 (2.12%)  11/183 (6.01%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  2/185 (1.08%)  12/189 (6.35%)  6/183 (3.28%) 
1
Term from vocabulary, MedDRA Version 21.0
*
Indicates events were collected by non-systematic assessment
Early termination of study/program due to a change in benefit-risk profile for individuals with early sporadic AD because of elevations in liver enzymes in participants receiving JNJ-54861911.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02569398    
Other Study ID Numbers: CR107373
2015-000948-42 ( EudraCT Number )
54861911ALZ2003 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: October 5, 2015
First Posted: October 6, 2015
Results First Submitted: December 20, 2019
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020