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)

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).

Study Overview

• Status: Completed
• Conditions: Age-Related Memory Disorders
• Intervention / Treatment: Drug: LX6171 High Dose; Drug: LX6171 Low Dose; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584
    • Kendle Netherlands
  • Zuidlaren, Netherlands, 9470
    • Pharmaceutical Research Associates Group BV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
Experimental: High Dose	Drug: LX6171 High Dose; A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.
Experimental: Low Dose	Drug: LX6171 Low Dose; A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration		Day 28
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.	Day 28
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.	Day 28
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.	Day 28
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.	Day 28
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.	Day 28

Collaborators and Investigators

• Sponsor: Lexicon Pharmaceuticals
• Investigators: Study Director: Philip M. Brown, M.D., J.D., Lexicon Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: June 2, 2008
• First Submitted That Met QC Criteria: June 3, 2008
• First Posted (Estimate): June 5, 2008

Study Record Updates

• Last Update Posted (Estimate): March 3, 2010
• Last Update Submitted That Met QC Criteria: February 17, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Memory Disorders
• Other Study ID Numbers: LX6171.1-201-AAMI; LX6171.201