期刊
DEMENTIA AND GERIATRIC COGNITIVE DISORDERS
卷 35, 期 5-6, 页码 325-339出版社
KARGER
DOI: 10.1159/000348347
关键词
Drug candidate AL-108; Davunetide; Mild cognitive impairment; Neuroprotection; Intranasal dosing; Dementia
资金
- Allon Therapeutics Inc. [AL-108-211]
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. Copyright (C) 2013 S. Karger AG, Basel
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