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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
History of Changes

June 2, 2008
February 17, 2010
February 2008
October 2008   (final data collection date for primary outcome measure)
  • 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 ]
To evaluate the safety and tolerability of 2 dose levels of LX6171 oral suspension when administered for 28 days in subjects exhibiting AAMI. [ Time Frame: Weekly assessment. Interim review after 18 subjects have completed 28 days of exposure. ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00691808 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Plasma concentration [ Time Frame: Weekly assessment. Interim review after 18 subjects have completed 28 days of exposure. ] [ Designated as safety issue: No ]
  • Cognitive assessment [ Time Frame: Weekly assessment. Interim review after 18 subjects have completed 28 days of exposure. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Age-Related Memory Disorders
  • 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.
  • 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.
  • Drug: Placebo
    Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.
  • Experimental: High Dose
    Intervention: Drug: LX6171 High Dose
  • Experimental: Low Dose
    Intervention: Drug: LX6171 Low Dose
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
Not Provided
October 2008   (final data collection date for primary outcome measure)

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)
Both
60 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00691808
LX6171.1-201-AAMI, LX6171.201
No
Medical Director, Lexicon Pharmaceuticals, Inc.
Lexicon Pharmaceuticals
Not Provided
Study Director: Philip M. Brown, M.D., J.D. Lexicon Pharmaceuticals, Inc.
Lexicon Pharmaceuticals
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP