NCT00630851已完成3 期
A Six-month, Multicenter, Double-blind, Parallel, Placebo-controlled Study of the Effect on Global/Behavioural/ADL Functions and Tolerability of Aricept in Patients Wtih Severe Alzheimer's Disease Living in an Assisted Care Facility
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.
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
- •Probable or possible Alzheimer's disease
- •Living in skilled nursing home
排除标准
- •Other types of dementia or psychiatric or neurologic disorders
- •Musculoskeletal disease
研究组 & 干预措施
1
Experimental
干预措施: Donepezil (Aricept) (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score
时间窗: Month 6
Change from baseline in Severe Impairment Battery (SIB) total score
时间窗: Month 6
次要结局
- Change from baseline in SIB total score(Month 3)
- Change from baseline in Neuropsychiatric Inventory (NPI) total score(Months 3 and 6)
- Change from baseline in modified ADCS-ADL-severe total score(Month 3)
- Change from inclusion in Mini Mental State Examination (MMSE) total score(Month 6)
- Change from baseline in Clinical Global Impression of Improvement (CGI-I) score(Months 3 and 6)
- Adverse events and laboratory value changes(Months 3 and 6)
研究者
研究点 (1)
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