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Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

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ClinicalTrials.gov Identifier: NCT00691808
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : March 3, 2010
Last Update Posted : March 3, 2010
Sponsor:
Information provided by:
Lexicon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 2, 2008
First Posted Date  ICMJE June 5, 2008
Results First Submitted Date  ICMJE November 17, 2009
Results First Posted Date  ICMJE March 3, 2010
Last Update Posted Date March 3, 2010
Study Start Date  ICMJE February 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
  • Number of Participants Who Were Exposed to LX6171 [ Time Frame: ≥28 days ]
  • Number of Participants Who Were Exposed to LX6171 [ Time Frame: 25 to 27 days ]
  • Number of Participants Who Were Exposed to LX6171 [ Time Frame: 14 to18 days ]
  • Number of Subjects Reporting at Least One Adverse Event (AE) [ Time Frame: 28 days ]
  • Number of Subjects Reporting Adverse Events Leading to Withdrawal [ Time Frame: 28 days ]
  • Treatment Compliance [ Time Frame: End of study ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
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. ]
Change History Complete list of historical versions of study NCT00691808 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
  • Plasma Concentration [ Time Frame: Day 28 ]
  • Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28 [ Time Frame: Day 28 ]
  • Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28 [ Time Frame: Day 28 ]
  • Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28 [ Time Frame: Day 28 ]
  • Change From Baseline in Pittsburgh Sleep Quality Index at Day 28 [ Time Frame: Day 28 ]
  • Change From Baseline in Epworth Sleepiness Scale at Day 28 [ Time Frame: Day 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
  • Plasma Concentration [ Time Frame: Weekly assessment. Interim review after 18 subjects have completed 28 days of exposure. ]
  • Cognitive assessment [ Time Frame: Weekly assessment. Interim review after 18 subjects have completed 28 days of exposure. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Memory Disorders
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: High Dose
    Intervention: Drug: LX6171 High Dose
  • Experimental: Low Dose
    Intervention: Drug: LX6171 Low Dose
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2010)
103
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)
120
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00691808
Other Study ID Numbers  ICMJE LX6171.1-201-AAMI
LX6171.201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Director, Lexicon Pharmaceuticals, Inc.
Study Sponsor  ICMJE Lexicon Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Philip M. Brown, M.D., J.D. Lexicon Pharmaceuticals, Inc.
PRS Account Lexicon Pharmaceuticals
Verification Date February 2010

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