NCT00096473已完成3 期
A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 229
- 试验地点
- 42
- 主要终点
- Assessments of global and cognitive function of Severe AD patients
研究概览
简要总结
Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer's disease.
Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person's memory to work better.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed Alzheimer's Disease with MMSE score 1~12
- •Have not been treated by any medication for Alzheimer's Disease in past 3 months
- •Live in community or Assisted Living Facility
- •Healthy or with chronic diseases that are medically controlled or stabilized
- •Able to swallow tablets
排除标准
- •Any primary neurological or psychiatric diagnosis (including depressive disorder) other than Alzheimer's Disease
- •Dementia caused by organic diseases other than Alzheimer's Disease
结局指标
主要结局
Assessments of global and cognitive function of Severe AD patients
次要结局
- Assessment of behavior and performance on Activity of Daily Living in severe AD patients
- Assessment of caregiver burden
研究者
研究点 (42)
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