Skip to main content
OpenTrials
Completed

NCT Number: NCT00691808

Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age-related Memory Disorders Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kendle Netherlands, Utrecht, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LX6171 High Dose

Drug

A high dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.

LX6171 Low Dose

Drug

A low dose of LX6171, using an oral suspension; daily oral intake for 28 days in the morning at approximately the same time.

Placebo

Drug

Matching placebo dosing with daily oral intake for 28 days in the morning at approximately the same time.

Primary outcomes

  1. Number of Participants Who Were Exposed to LX6171

    Time frame: ≥28 days

  2. Number of Participants Who Were Exposed to LX6171

    Time frame: 25 to 27 days

  3. Number of Participants Who Were Exposed to LX6171

    Time frame: 14 to18 days

  4. Number of Subjects Reporting at Least One Adverse Event (AE)

    Time frame: 28 days

    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.

  5. Number of Subjects Reporting Adverse Events Leading to Withdrawal

    Time frame: 28 days

  6. Treatment Compliance

    Time frame: End of study

    Subjects were considered compliant if they had taken >70% of possible doses of the study drug.

Secondary outcomes

  1. Plasma Concentration

    Time frame: Day 28

  2. Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28

    Time frame: 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.

  3. Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28

    Time frame: 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.

  4. Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28

    Time frame: 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.

  5. Change From Baseline in Pittsburgh Sleep Quality Index at Day 28

    Time frame: 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.

  6. Change From Baseline in Epworth Sleepiness Scale at Day 28

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lexicon Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2008
First posted
Jun 5, 2008
Registry last updated
Mar 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.