Phase 2
Completed N=103
Study of LX6171 in Elderly Volunteers With Age Associated Memory Impairment
Age-Related Memory Disorders
Source: ClinicalTrials.gov NCT00691808 ↗
Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcomePrimary: Number of Participants Who Were Exposed to LX6171 — 35; 33; 31 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Were Exposed to LX6171 |
0; 1; 0 | — |
| PRIMARY Number of Subjects Reporting at Least One Adverse Event (AE) |
25; 22; 26 | — |
| PRIMARY Number of Subjects Reporting Adverse Events Leading to Withdrawal |
0; 1; 0 | — |
| PRIMARY Treatment Compliance |
100.0; 99.80; 99.89 | — |
| SECONDARY Plasma Concentration |
4670; 2300; 0 | — |
| SECONDARY Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28 |
-1.2; -1.9; -1.1 | — |
| SECONDARY Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28 |
-1.5; -1.7; -2.3 | — |
| SECONDARY Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28 |
0.9; -2.4; 2.5 | — |
| SECONDARY Change From Baseline in Pittsburgh Sleep Quality Index at Day 28 |
0.3; 0.3; 0.7 | — |
| SECONDARY Change From Baseline in Epworth Sleepiness Scale at Day 28 |
-0.9; 0; -0.6 | — |
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)
Data sourced from ClinicalTrials.gov (NCT00691808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.