[1]Department of Geriatric Psychiatry, Shanghai Mental Health Center, Shanghai Jiao Tong University, Shanghai, China.
Background: The octohydroaminoacridine, a new humanized acetylcholinesterase inhibitor, is a potential treatment for Alzheimer"s disease. Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 clinical trial to investigate the effects of octohydroaminoacridine in patients with mild-to-moderate Alzheimer"s disease. 284 patients were randomized to receive placebo thrice-daily (TID), octohydroaminoacridine 1 mg TID (low dose group), or to titrate up to 2 mg TID (middle dose group) in two weeks, or to titrated up to 4 mg TID (high dose group) in four weeks. Changes from baseline to week 16 were assessed with the Alzheimer"s Disease Assessment Scale-Cognitive Subscale (ADAS-cog), Clinician"s Interview- Based Impression of Change Plus (CIBIC+), Activities of Daily Living (ADL) and the Neuropsychiatric Inventory (NPI). A 2- way analysis of covariance and least squares mean (LSM) t-test were used. (ClinicalTrials.gov Identifier: NCT01569516). Results: In this study, 71, 70, 71 and 72 patients were randomized to low dose group, middle dose group, high dose group, and placebo group, respectively. At week 16, the between-group differences of the change from baseline in the primary outcome of ADAScog (octohydroaminoacridine groups minus placebo group) were 3.16, 3.27 and 5.01 for low, middle, and high dose groups, respectively (p<0.0001 for all these tests). For secondary outcomes, the patients in three drug groups had better performance in CIBICplus score and ADL score, but there were no significant betweengroup differences in NPI score. There was not any evidence for more adverse events occurred in different drug groups than placebo group. Conclusions: Octohydroaminoacridine significantly improved cognitive function and behavior among these patients with mild-to-moderate Alzheimer"s disease. (Figure Presented).
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