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 …

BH Morimoto, D Schmechel, J Hirman… - Dementia and geriatric …, 2013 - karger.com
BH Morimoto, D Schmechel, J Hirman, A Blackwell, J Keith, M Gold…
Dementia and geriatric cognitive disorders, 2013karger.com
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 …
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.
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