Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

Phase 2

Completed

• Conditions: Age-Related Memory Disorders
• Interventions: Drug: LX6171 Low Dose; Drug: LX6171 High Dose; Drug: Placebo

• Registration Number: NCT00691808
• Lead Sponsor: Lexicon Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-05
• Primary Completion: 2008-10
• Results First Submitted: 2009-11-17
• Status Verified: 2010-02
• Results First Submitted QC: 2010-02-17
• Last Update Submitted: 2010-02-17
• Results First Posted: 2010-03-03
• Last Update Posted: 2010-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	LX6171 Low Dose	-
High Dose	LX6171 High Dose	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting at Least One Adverse Event (AE)	28 days	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.
Treatment Compliance	End of study	Subjects were considered compliant if they had taken \>70% of possible doses of the study drug.
Number of Participants Who Were Exposed to LX6171	14 to18 days
Number of Subjects Reporting Adverse Events Leading to Withdrawal	28 days

Secondary Outcome Measures

Name	Time	Method
Plasma Concentration	Day 28
Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28	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 (Day -1) in 15-Words Test: Acquisition Score at Day 28	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	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 Pittsburgh Sleep Quality Index at Day 28	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	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.

Trial Locations

Locations (2)

Pharmaceutical Research Associates Group BV; 🇳🇱 Zuidlaren, Netherlands

Kendle Netherlands; 🇳🇱 Utrecht, Netherlands