A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease
- Registration Number
- NCT01404169
- Lead Sponsor
- Eisai Limited
- Brief Summary
The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 E2020 -
- Primary Outcome Measures
Name Time Method The change in the total Severe Impairment Battery (SIB) score at Week 24 24 weeks All statistical tests will be conducted at the 0.05 level of significance (two-tailed). A positive outcome will be declared if for the primary efficacy endpoint as measured by the Severe Impairment Battery (SIB), the change from Baseline to Week 24 in the total SIB score last observation carried forward (LOCF) demonstrates superiority for donepezil 10 mg, compared with placebo.
- Secondary Outcome Measures
Name Time Method Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24 24 weeks An ANCOVA with embedded Cochran-Mantel-Haenszel (CMH) test will be used with the CIBIC+ and center in the model. Overall change from Baseline in scores at Week 24 (LOCF) will be analyzed with the same model as the SIB.
Trial Locations
- Locations (32)
Beijing Hospital
🇨🇳Beijing, Beijing, China
Beijing Huilongguan Hospital
🇨🇳Beijing, Beijing, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Guangzhou Brain Hospital
🇨🇳Guangzhou, Guangdong, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First People's Hospital of YueYang
🇨🇳Yueyang, Hunan, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Union Hospital, Tongji Medical college Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Nanjing Brain Hospital
🇨🇳Nanjing Jiangsu, China
The Second Hospital of Shandong University
🇨🇳Jinan, Shandong, China
The Affiliated Hospital of Medical College Qingdao University
🇨🇳Qingdao, Shandong, China
Tangdu Hospital, The Fourth Military Medical University
🇨🇳Xi'An, Shanxi, China
Xi'An Mental Health Center
🇨🇳Xi'An, Shanxi, China
Xijing Hospital, The Fourth Military Medical University
🇨🇳Xi'An, Shanxi, China
First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The Second Affiliated Hospital to Nanchang University
🇨🇳Nanchang, China
Tianjin People's Hospital
🇨🇳Tianjin, China
Tianjin Anding Hospital
🇨🇳Tianjin, China
Beijing Anding Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Hushan Hospital affliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
The Second Affiliated hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Tongji Hospital, Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
Shanghai Ruijin Hospital
🇨🇳Shanghai, Shanghai, China