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)
Overview
- Phase
- Phase 2
- Intervention
- LX6171 High Dose
- Conditions
- Age-Related Memory Disorders
- Sponsor
- Lexicon Pharmaceuticals
- Enrollment
- 103
- Locations
- 2
- Primary Endpoint
- Number of Subjects Reporting at Least One Adverse Event (AE)
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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).
Investigators
Eligibility 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)
Arms & Interventions
High Dose
Intervention: LX6171 High Dose
Low Dose
Intervention: LX6171 Low Dose
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Treatment Compliance
Time Frame: End of study
Subjects were considered compliant if they had taken \>70% of possible doses of the study drug.
Number of Participants Who Were Exposed to LX6171
Time Frame: 14 to18 days
Number of Subjects Reporting Adverse Events Leading to Withdrawal
Time Frame: 28 days
Secondary Outcomes
- Plasma Concentration(Day 28)
- Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28(Day 28)
- Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28(Day 28)
- Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28(Day 28)
- Change From Baseline in Pittsburgh Sleep Quality Index at Day 28(Day 28)
- Change From Baseline in Epworth Sleepiness Scale at Day 28(Day 28)