title: 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: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  These data suggest that AL-108 was generally safe, well tolerated and merits additional investigation as a treatment for Alzheimer's disease.
authors.affiliation: Allon Therapeutics Inc., Vancouver, B.C., Canada.
authors.forename: Bruce H
authors.initials: BH
authors.lastname: Morimoto
authors.forename: Don
authors.initials: D
authors.lastname: Schmechel
authors.forename: Joe
authors.initials: J
authors.lastname: Hirman
authors.forename: Andrew
authors.initials: A
authors.lastname: Blackwell
authors.forename: Julian
authors.initials: J
authors.lastname: Keith
authors.forename: Michael
authors.initials: M
authors.lastname: Gold
mesh_terms: D000281:Administration, Intranasal; D000368:Aged; D000369:Aged, 80 and over; D003071:Cognition / Q000187:drug effects*; D060825:Cognitive Dysfunction / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008570:Memory, Short-Term / Q000187:drug effects; D008875:Middle Aged; D009483:Neuropsychological Tests; D009842:Oligopeptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010153:Paired-Associate Learning / Q000187:drug effects; D010349:Patient Compliance; D013028:Space Perception / Q000187:drug effects
chemical_list: D009842:Oligopeptides; C425904:davunetide