A double-blind, placebo-controlled, ascending-dose, randomized study to evaluate the safety, tolerability and effects on cognition of AL-108 after 12 weeks of intranasal administration in subjects with mild cognitive impairment.

Abstract

BACKGROUND/AIMS:

AL-108-211 was a placebo-controlled, ascending-dose study that explored the safety, tolerability and efficacy of 12 weeks of treatment with AL-108 in subjects with amnestic mild cognitive impairment.

METHODS:

A total of 144 subjects were randomized in a 2:1 drug:placebo ratio. Subjects were enrolled into the low-dose group or placebo and then to the high-dose group or placebo. Pooling of the placebo groups yielded 3 groups (approx. 48/group) whose baseline demographics and disease characteristics were well matched.

RESULTS:

AL-108 was generally safe and well tolerated. Analyses of efficacy data failed to detect a statistically significant difference between the treatment groups on the composite cognitive memory score. Analyses of the individual cognitive tasks identified signals of potential efficacy in 2 tests of memory and attention.

CONCLUSION:

These data suggest that AL-108 was generally safe, well tolerated and merits additional investigation as a treatment for Alzheimer's disease.

• Authors: Bruce H Morimoto, Don Schmechel, Joe Hirman, Andrew Blackwell, Julian Keith, Michael Gold, AL-108-211 Study
• Journal: Dementia and geriatric cognitive disorders (Dement Geriatr Cogn Disord) Vol. 35 Issue 5-6 Pg. 325-36 ( 2013) ISSN: 1421-9824 [Electronic] Switzerland
• PMID: 23594991 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 S. Karger AG, Basel.

Chemical References

• Oligopeptides
• davunetide

Topics

• Administration, Intranasal
• Aged
• Aged, 80 and over
• Cognition (drug effects)
• Cognitive Dysfunction (drug therapy, psychology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Male
• Memory, Short-Term (drug effects)
• Middle Aged
• Neuropsychological Tests
• Oligopeptides (administration & dosage, adverse effects, therapeutic use)
• Paired-Associate Learning (drug effects)
• Patient Compliance
• Space Perception (drug effects)