Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

This study has been completed.
Sponsor:
Information provided by:
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00691808
First received: June 2, 2008
Last updated: February 17, 2010
Last verified: February 2010
  Purpose

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).


Condition Intervention Phase
Age-Related Memory Disorders
Drug: LX6171 High Dose
Drug: LX6171 Low Dose
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Lexicon Pharmaceuticals:

Primary Outcome Measures:
  • Number of Participants Who Were Exposed to LX6171 [ Time Frame: ≥28 days ] [ Designated as safety issue: No ]
  • Number of Participants Who Were Exposed to LX6171 [ Time Frame: 25 to 27 days ] [ Designated as safety issue: No ]
  • Number of Participants Who Were Exposed to LX6171 [ Time Frame: 14 to18 days ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting at Least One Adverse Event (AE) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Adverse Events Leading to Withdrawal [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Treatment Compliance [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma Concentration [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change From Baseline in Pittsburgh Sleep Quality Index at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Change From Baseline in Epworth Sleepiness Scale at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: February 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Placebo Comparator: Placebo Drug: Placebo
Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691808

Locations
Netherlands
Kendle Netherlands
Utrecht, Netherlands, 3584
Pharmaceutical Research Associates Group BV
Zuidlaren, Netherlands, 9470
Sponsors and Collaborators
Lexicon Pharmaceuticals
Investigators
Study Director: Philip M. Brown, M.D., J.D. Lexicon Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Medical Director, Lexicon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00691808     History of Changes
Other Study ID Numbers: LX6171.1-201-AAMI, LX6171.201
Study First Received: June 2, 2008
Results First Received: November 17, 2009
Last Updated: February 17, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014