Aricept Approved to Treat Severe as Well as Milder Alzheimer’s Disease in China

Aricept Approved to Treat Severe as Well as Milder Alzheimer’s Disease in China
Aricept (donepezil hydrochloride) is now approved in China to treat patients with severe Alzheimer’s disease, as well as those with mild or moderate disease, Eisai recently announced. The extended approval was based on the results of a Phase 3 clinical trial (NCT01404169) conducted in that country. The study was designed to evaluate the efficacy and safety of Aricept 10 mg per day in 313 Chinese patients with severe Alzheimer’s. Results showed statistically significant improvement in total severe impairment battery scores after 24 weeks of treatment compared to placebo. This measure was the study's primary endpoint. Secondary study goals judged clinician impressions of benefit, where statistically significant improvements were recorded, and a change in mini-mental state examination (MMSE) scores, a method for assessing cognitive function, where the difference between treated and placebo groups did not attain statistical significance, the company noted in a press release. Most common adverse events recorded were bradycardia (slow heart rate), anorexia, QT interval (a measure of heart rate) prolongation and dizziness. Aricept was approved in China to treat patients with mild and moderate Alzheimer's in September 1999. Since then, together with other stakeholders including the Chinese government, hospitals and non-governmental organizations, Eisai has been helping to build a support network by establishing memory clinics and other initiatives. Study findings were published in
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