Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
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)
2 other identifiers
interventional
103
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 2, 2008
CompletedFirst Posted
Study publicly available on registry
June 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedResults Posted
Study results publicly available
March 3, 2010
CompletedMarch 3, 2010
February 1, 2010
8 months
June 2, 2008
November 17, 2009
February 17, 2010
Conditions
Outcome Measures
Primary Outcomes (6)
Number of Participants Who Were Exposed to LX6171
≥28 days
Number of Participants Who Were Exposed to LX6171
25 to 27 days
Number of Participants Who Were Exposed to LX6171
14 to18 days
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.
28 days
Number of Subjects Reporting Adverse Events Leading to Withdrawal
28 days
Treatment Compliance
Subjects were considered compliant if they had taken \>70% of possible doses of the study drug.
End of study
Secondary Outcomes (6)
Plasma Concentration
Day 28
Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28
Day 28
Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28
Day 28
Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28
Day 28
Change From Baseline in Pittsburgh Sleep Quality Index at Day 28
Day 28
- +1 more secondary outcomes
Study Arms (3)
High Dose
EXPERIMENTALLow Dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kendle Netherlands
Utrecht, 3584, Netherlands
Pharmaceutical Research Associates Group BV
Zuidlaren, 9470, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joel P. Freiman, MD, MPH - Medical Director, Drug safety
- Organization
- Lexicon Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Philip M. Brown, M.D., J.D.
Lexicon Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 2, 2008
First Posted
June 5, 2008
Study Start
February 1, 2008
Primary Completion
October 1, 2008
Last Updated
March 3, 2010
Results First Posted
March 3, 2010
Record last verified: 2010-02