Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) today submitted an application for a new indication of Aricept
(donepezil hydrochloride) for severe Alzheimer's disease in Japan.
The application includes the results of a 6-month placebo-controlled, randomized double-blind study comparing the efficacy of 5 mg/day and 10 mg/day doses of Aricept
to placebo which was performed with the participation of 300 severe Alzheimer's disease patients in Japan.
In this study, 5 mg/day and 10 mg/day doses of Aricept
statistically showed a significant effect on the cognitive function of severe Alzheimer's disease patients compared to placebo. Moreover, 10 mg/day dose of Aricept
showed a statistically significant improvement in the overall clinical condition of patients compared to placebo. 5 mg/day dose of Aricept
did not show any statistically significant effect on the occurrence of side effects compared to placebo while patients taking 10 mg/day dose of Aricept
experienced a statistically significantly higher incidence of mostly mild to moderate gastrointestinal side effects compared to placebo.
, an acetylcholinesterase inhibitor developed by Eisai Co., Ltd., increases the concentration of acetylcholine, a neurotransmitter in the brain. Aricept
is currently indicated for the treatment of mild to moderate Alzheimer's disease and the estimated number of patients are approximately 1 million in Japan.
Eisai will make an effort to enhance the clinical value of Aricept
through this application, and aims to contribute to the benefit of all patients suffering from the full range of mild to severe Alzheimer's disease in Japan.
Corporate Communications Department
Eisai Co., Ltd.