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 the Journal of Alzheimer’s Disease, under the title “Efficacy and safety of donepezil in Chinese patients with severe Alzheimer’s disease: A randomized controlled trial.”
An estimated six million people live with Alzheimer’s disease in China, and the number of Alzheimer’s and dementia patients is expected to increase as the population ages. According to a 2017 Forbes article, China’s population is aging more rapidly than almost any country in recent history. Its dependency ratio for retirees — the balance between those who are or could be in the labor force and those who cannot — could rise to 44 percent by 2050.
Since Alzheimer’s and dementia are conditions associated with aging, China could be dealing with “an explosion” of these cases in the future. One study predicts that Alzheimer’s prevalence will quadruple in China by 2050, rising from about six million affected today to about 28 million in some 32 years.
Aricept has been approved for use in Alzheimer’s patients with mild, moderate or severe disease by the U.S. Food and Drug Administration since 2010.