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

Dement Geriatr Cogn Disord. 2013;35(5-6):325-36. doi: 10.1159/000348347. Epub 2013 Apr 13.


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.

Trial registration: ClinicalTrials.gov NCT00422981.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

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


  • Oligopeptides
  • davunetide

Associated data

  • ClinicalTrials.gov/NCT00422981