Date: 2014-09-30
Type of information: Results
phase: 3
Announcement: results
Company: Eisai (Japan)
Product: Aricept® (donepezil hydrochloride)
Action mechanism:
Disease: severe Alzheimer\'s disease
Therapeutic area: Neurodegenerative diseases
Country: China
Trial details:
Latest
news: * On September 30, 2014, Eisai announced that a Phase III clinical trial (Study 339) conducted in China of Aricept® (donepezil hydrochloride) in patients with severe Alzheimer\'s Disease (AD) met its primary endpoint. Based on the results of the study, Eisai plans to submit an application during fiscal 2014 to the regulatory authority in China for an indication expansion to include the treatment of severe AD. The trial was a multi-center, randomized, double-blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of Aricept® 10 mg tablets in 313 Chinese patients with severe AD. Analysis of the results of the study demonstrated that Aricept® statistically significantly improved total Severe Impairment Battery scores after 24 weeks compared to placebo, which was the primary endpoint of the study. In this study, the most commonly observed adverse events were bradycardia, anorexia, QT interval prolongation, dizziness, diarrhea and weight loss.
