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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014