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.
RCT Entities:
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: N Amram; G Hacohen-Kleiman; S Sragovich; A Malishkevich; J Katz; O Touloumi; R Lagoudaki; N C Grigoriadis; E Giladi; A Yeheskel; M Pasmanik-Chor; Y Jouroukhin; I Gozes Journal: Mol Psychiatry Date: 2016-01-19 Impact factor: 15.992
Authors: Adam L Boxer; Anthony E Lang; Murray Grossman; David S Knopman; Bruce L Miller; Lon S Schneider; Rachelle S Doody; Andrew Lees; Lawrence I Golbe; David R Williams; Jean-Cristophe Corvol; Albert Ludolph; David Burn; Stefan Lorenzl; Irene Litvan; Erik D Roberson; Günter U Höglinger; Mary Koestler; Clifford R Jack; Viviana Van Deerlin; Christopher Randolph; Iryna V Lobach; Hilary W Heuer; Illana Gozes; Lesley Parker; Steve Whitaker; Joe Hirman; Alistair J Stewart; Michael Gold; Bruce H Morimoto Journal: Lancet Neurol Date: 2014-05-27 Impact factor: 44.182