Non-Interventional Study With Aricept® Evess In Patients Diagnosed With Mild And Moderate Alzheimer's Disease Or Vascular Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)
研究概览
简要总结
The Aricept® Evess study is a prospective, non-comparative, non-interventional study on use of Aricept® Evess in the treatment of out-patients with AD and Vascular Dementia. The 24 week length of the study aims to collect data from a large number of patients (n= 400) on the safety and efficacy at the usual dosage of the product providing an overview of Aricept® Evess profile.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Outpatients (male / female), older than 50 years.
- •Patients with clinical symptoms of mild and moderate AD and Vascular Dementia.
- •MMSE score between 12 - 24.
排除标准
- •Patients with a known hypersensitivity to donepezil clorhydrat, piperidine derivatives or any of the excipients of Aricept® Evess.
- •Patients with severe impaired hepatic function.
- •Patients with pre-existing gastrointestinal ulcer disease.
- •Patients with the history of bronchial asthma or chronic obstructive lung disease.
- •Patients with the history of serious atrioventricular conduction disturbances.
研究组 & 干预措施
1
干预措施: Aricept® Evess (Drug)
结局指标
主要结局
Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)
时间窗: Baseline and Week 24
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline.
次要结局
- Change From Baseline in MMSE Total(Baseline, Week 8, 16, and 24)
- Change From Baseline in Functional Activity Questionnaire (FAQ)(Baseline and Week 24)
- Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8(Week 8)
- Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16(Week 16)
- Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24(Week 24)
- Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF(Week 24)
- Number of Participants in Each Patient Domain of Benefit(Week 24)