Title
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)
Phase
Phase 2Lead Sponsor
Lexicon PharmaceuticalsStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Age-Related Memory DisordersIntervention/Treatment
lx6171 ...Study Participants
103The 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).
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.
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)
| Event Type | Organ System | Event Term | High Dose | Low Dose | Placebo |
|---|
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.
Subjects were considered compliant if they had taken >70% of possible doses of the study drug.
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.
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.
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.
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.
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.
