Back to resultsStudy of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
Primary Purpose
Age-Related Memory Disorders
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
LX6171 High Dose
LX6171 Low Dose
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Memory Disorders
Eligibility Criteria
Inclusion Criteria:
- Males and females aged 60-80 years old.
- Complaints of memory loss in everyday life
- Non-smokers or very light smokers (no more than 10 cigarettes/day)
- Negative urine screen for drugs of abuse
- Ability to provide written informed consent
Exclusion Criteria:
- History or evidence of any disease, disorder or injury that could cause cognitive deterioration.
- Need for medications other than hormone replacement therapy, daily vitamins, or over-the-counter pain killers
- Clinically significant abnormality on electrocardiogram
- History of alcoholism or drug dependence
- Use of dietary supplements containing Huperzine A, gingko biloba, phosphatidylserine, or Docosahexaenoic acid (DHA)
Sites / Locations
- Kendle Netherlands
- Pharmaceutical Research Associates Group BV
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
High Dose
Low Dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Who Were Exposed to LX6171
Number of Participants Who Were Exposed to LX6171
Number of Participants Who Were Exposed to LX6171
Number of Subjects Reporting at Least One Adverse Event (AE)
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.
Number of Subjects Reporting Adverse Events Leading to Withdrawal
Treatment Compliance
Subjects were considered compliant if they had taken >70% of possible doses of the study drug.
Secondary Outcome Measures
Plasma Concentration
Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28
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.
Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28
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.
Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28
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.
Change From Baseline in Pittsburgh Sleep Quality Index at Day 28
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.
Change From Baseline in Epworth Sleepiness Scale at Day 28
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.
Full Information
NCT ID
NCT00691808
First Posted
June 2, 2008
Last Updated
February 17, 2010
Sponsor
Lexicon Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00691808
Brief Title
Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
Official Title
A Randomized, Double-Blind, Placebo-Controlled Study to Determine Safety and Tolerability of LX6171 Oral Suspension Dosed for 28 Days in Subjects Exhibiting Age Associated Memory Impairment (AAMI)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Lexicon Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients with Age Associated Memory Impairment (AAMI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Memory Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose
Arm Type
Experimental
Arm Title
Low Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LX6171 High Dose
Intervention Description
A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
Intervention Type
Drug
Intervention Name(s)
LX6171 Low Dose
Intervention Description
A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
Primary Outcome Measure Information:
Title
Number of Participants Who Were Exposed to LX6171
Time Frame
≥28 days
Title
Number of Participants Who Were Exposed to LX6171
Time Frame
25 to 27 days
Title
Number of Participants Who Were Exposed to LX6171
Time Frame
14 to18 days
Title
Number of Subjects Reporting at Least One Adverse Event (AE)
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
Title
Number of Subjects Reporting Adverse Events Leading to Withdrawal
Time Frame
28 days
Title
Treatment Compliance
Description
Subjects were considered compliant if they had taken >70% of possible doses of the study drug.
Time Frame
End of study
Secondary Outcome Measure Information:
Title
Plasma Concentration
Time Frame
Day 28
Title
Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28
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
Title
Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28
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
Title
Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28
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
Title
Change From Baseline in Pittsburgh Sleep Quality Index at Day 28
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
Title
Change From Baseline in Epworth Sleepiness Scale at Day 28
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females aged 60-80 years old.
Complaints of memory loss in everyday life
Non-smokers or very light smokers (no more than 10 cigarettes/day)
Negative urine screen for drugs of abuse
Ability to provide written informed consent
Exclusion Criteria:
History or evidence of any disease, disorder or injury that could cause cognitive deterioration.
Need for medications other than hormone replacement therapy, daily vitamins, or over-the-counter pain killers
Clinically significant abnormality on electrocardiogram
History of alcoholism or drug dependence
Use of dietary supplements containing Huperzine A, gingko biloba, phosphatidylserine, or Docosahexaenoic acid (DHA)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip M. Brown, M.D., J.D.
Organizational Affiliation
Lexicon Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kendle Netherlands
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands
Facility Name
Pharmaceutical Research Associates Group BV
City
Zuidlaren
ZIP/Postal Code
9470
Country
Netherlands
12. IPD Sharing Statement
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Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
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