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Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

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ClinicalTrials.gov Identifier: NCT00691808
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : March 3, 2010
Last Update Posted : March 3, 2010
Sponsor:
Information provided by:
Lexicon Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Age-Related Memory Disorders
Interventions Drug: LX6171 High Dose
Drug: LX6171 Low Dose
Drug: Placebo
Enrollment 103
Recruitment Details The study was performed at 2 centers in the Netherlands, one in Utrecht and one in Zuidlaren. Recruitment began in October of 2007 and the last subject completed the study in October of 2008.
Pre-assignment Details  
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description 240 mg LX6171 oral suspension administered once per day 120 mg LX6171 oral suspension administered once per day Placebo dosing volume-matched and administered once per day
Period Title: Overall Study
Started 35 36 32
Completed 35 35 32
Not Completed 0 1 0
Arm/Group Title High Dose Low Dose Placebo Total
Hide Arm/Group Description 240 mg LX6171 oral suspension administered once per day 120 mg LX6171 oral suspension administered once per day Placebo dosing volume-matched and administered once per day Total of all reporting groups
Overall Number of Baseline Participants 35 36 32 103
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 36 participants 32 participants 103 participants
65.97  (3.48) 67.81  (4.79) 67.37  (4.41) 67.05  (4.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 32 participants 103 participants
Female
16
  45.7%
16
  44.4%
12
  37.5%
44
  42.7%
Male
19
  54.3%
20
  55.6%
20
  62.5%
59
  57.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 35 participants 36 participants 32 participants 103 participants
Asian 0 0 1 1
Black or African American 1 0 0 1
White 34 36 31 101
1.Primary Outcome
Title Number of Participants Who Were Exposed to LX6171
Hide Description [Not Specified]
Time Frame ≥28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Measure Type: Number
Unit of Measure: Participants
35 33 31
2.Primary Outcome
Title Number of Participants Who Were Exposed to LX6171
Hide Description [Not Specified]
Time Frame 25 to 27 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Measure Type: Number
Unit of Measure: Participants
0 2 1
3.Primary Outcome
Title Number of Participants Who Were Exposed to LX6171
Hide Description [Not Specified]
Time Frame 14 to18 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Measure Type: Number
Unit of Measure: Participants
0 1 0
4.Primary Outcome
Title Number of Subjects Reporting at Least One Adverse Event (AE)
Hide Description An adverse event includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not associated with the study medication and whether or not considered related to study medication.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Measure Type: Number
Unit of Measure: Participants
25 22 26
5.Primary Outcome
Title Number of Subjects Reporting Adverse Events Leading to Withdrawal
Hide Description [Not Specified]
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Measure Type: Number
Unit of Measure: Participants
0 1 0
6.Primary Outcome
Title Treatment Compliance
Hide Description Subjects were considered compliant if they had taken >70% of possible doses of the study drug.
Time Frame End of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Mean (Standard Deviation)
Unit of Measure: Percentage of Participants
100.0  (0) 99.80  (0.84) 99.89  (0.64)
7.Secondary Outcome
Title Plasma Concentration
Hide Description [Not Specified]
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Mean (Standard Deviation)
Unit of Measure: ng/mL
4670  (1470) 2300  (618) 0  (0)
8.Secondary Outcome
Title Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28
Hide Description The 15-Words Test is used to measure verbal learning and memory. Subjects are scored on the number of recognized words on a scale of 0-15, with 0 being the worst and 15 being the best. The baseline (Day -1) score was subtracted from the Day 28 score to obtain the Score Change from Baseline.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Mean (Standard Deviation)
Unit of Measure: Number of words
-1.2  (7.6) -1.9  (5.6) -1.1  (6.8)
9.Secondary Outcome
Title Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28
Hide Description Subjects are asked to recall words from the preceding week's 15-Words Test. Baseline (Day -1) scores (scale 0-15, 0 being the worst) were subtracted from Day 28 scores to obtain the score change from baseline.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Mean (Standard Deviation)
Unit of Measure: Number of words
-1.5  (2.3) -1.7  (2.2) -2.3  (2.6)
10.Secondary Outcome
Title Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28
Hide Description The subjects were asked to describe their memory ability in a variety of situations of everyday life (a list of 25 questions) using a 5-point scale, with a lower score being a negative assessment. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.9  (5.9) -2.4  (6.0) 2.5  (6.0)
11.Secondary Outcome
Title Change From Baseline in Pittsburgh Sleep Quality Index at Day 28
Hide Description The Pittsburgh Sleep Quality Index is a self-rated questionnaire that assesses sleep quality and disturbances. Responses were scored on a scale of 0 to 3 where 3 is the negative extreme. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.3  (1.1) 0.3  (1.7) 0.7  (1.8)
12.Secondary Outcome
Title Change From Baseline in Epworth Sleepiness Scale at Day 28
Hide Description The Epworth Sleepiness Scale is a self-administered questionnaire used to help quantify a subject's level of daytime sleepiness. Subjects recorded their chances of dozing on a scale of 0 to 3, with 0 being no chance and 3 being a high chance. Baseline (Day -1) scores were subtracted from Day 28 scores to obtain score change from baseline.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description:
240 mg LX6171 oral suspension administered once per day
120 mg LX6171 oral suspension administered once per day
Placebo dosing volume-matched and administered once per day
Overall Number of Participants Analyzed 35 36 32
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.9  (2.0) 0  (2.6) -0.6  (2.1)
Time Frame 35 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Low Dose Placebo
Hide Arm/Group Description 240 mg LX6171 oral suspension administered once per day 120 mg LX6171 oral suspension administered once per day Placebo dosing volume-matched and administered once per day
All-Cause Mortality
High Dose Low Dose Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
High Dose Low Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/36 (0.00%)      0/32 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
High Dose Low Dose Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/35 (71.43%)      22/36 (61.11%)      26/32 (81.25%)    
Gastrointestinal disorders       
Abdominal discomfort * 1  1/35 (2.86%)  1 0/36 (0.00%)  0 2/32 (6.25%)  4
Abdominal pain * 1  3/35 (8.57%)  4 3/36 (8.33%)  3 5/32 (15.63%)  5
Abdominal pain upper * 1  0/35 (0.00%)  0 1/36 (2.78%)  1 2/32 (6.25%)  3
Diarrhea * 1  3/35 (8.57%)  3 2/36 (5.56%)  2 7/32 (21.88%)  10
Nausea * 1  3/35 (8.57%)  3 2/36 (5.56%)  2 2/32 (6.25%)  2
General disorders       
Fatigue * 1  1/35 (2.86%)  1 3/36 (8.33%)  3 1/32 (3.13%)  1
Infections and infestations       
Rhinitis * 1  1/35 (2.86%)  1 3/36 (8.33%)  3 3/32 (9.38%)  3
Musculoskeletal and connective tissue disorders       
Back pain * 1  2/35 (5.71%)  2 0/36 (0.00%)  0 3/32 (9.38%)  3
Myalgia * 1  1/35 (2.86%)  1 0/36 (0.00%)  0 2/32 (6.25%)  3
Nervous system disorders       
Dizziness * 1  5/35 (14.29%)  6 5/36 (13.89%)  5 1/32 (3.13%)  1
Headache * 1  10/35 (28.57%)  20 5/36 (13.89%)  8 9/32 (28.13%)  16
Somnolence * 1  3/35 (8.57%)  3 3/36 (8.33%)  5 2/32 (6.25%)  2
Early morning awakening * 1  1/35 (2.86%)  1 2/36 (5.56%)  2 0/32 (0.00%)  0
Insomnia * 1  5/35 (14.29%)  5 2/36 (5.56%)  3 1/32 (3.13%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
The sponsor requires that written permission be given before the investigator can release any data publicly.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Joel P. Freiman, MD, MPH - Medical Director, Drug safety
Organization: Lexicon Pharmaceuticals, Inc.
Phone: 281-863-3000
Layout table for additonal information
Responsible Party: Medical Director, Lexicon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00691808     History of Changes
Other Study ID Numbers: LX6171.1-201-AAMI
LX6171.201
First Submitted: June 2, 2008
First Posted: June 5, 2008
Results First Submitted: November 17, 2009
Results First Posted: March 3, 2010
Last Update Posted: March 3, 2010