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

PHASE3CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

July 31, 2014

Study Completion Date

September 30, 2014

Conditions
Alzheimer's Type Dementia
Interventions
DRUG

E2020

In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period.

DRUG

Placebo

Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.

Trial Locations (32)

Unknown

Beijing Anding Hospital, Beijing

Beijing Hospital, Beijing

Beijing Huilongguan Hospital, Beijing

Chinese PLA General Hospital, Beijing

Xuanwu Hospital Capital Medical University, Beijing

The First Affiliated Hospital of Chongqing Medical University, Chongqing

The Second Affiliated Hospital of Chongqing Medical University, Chongqing

Guangzhou Brain Hospital, Guangzhou

Guangzhou First People's Hospital, Guangzhou

The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning

Tongji Hospital, Tongji Medical College of HUST, Wuhan

Union Hospital, Tongji Medical college Huazhong University of Science and Technology, Wuhan

The Third Xiangya Hospital of Central South University, Changsha

The First People's Hospital of YueYang, Yueyang

Qilu Hospital of Shandong University, Jinan

The Second Hospital of Shandong University, Jinan

The Affiliated Hospital of Medical College Qingdao University, Qingdao

Hushan Hospital affliated to Fudan University, Shanghai

Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

Shanghai Changzheng Hospital, Shanghai

Shanghai Ruijin Hospital, Shanghai

Tangdu Hospital, The Fourth Military Medical University, Xi’an

Xi'An Mental Health Center, Xi’an

Xijing Hospital, The Fourth Military Medical University, Xi’an

Sichuan Provincial People's Hospital, Chengdu

West China Hospital, Sichuan University, Chengdu

First Affiliated Hospital of Kunming Medical University, Kunming

The Second Affiliated hospital of Zhejiang University School of Medicine, Hangzhou

The Second Affiliated Hospital to Nanchang University, Nanchang

Nanjing Brain Hospital, Nanjing Jiangsu

Tianjin Anding Hospital, Tianjin

Tianjin People's Hospital, Tianjin

All Listed Sponsors
lead

Eisai Limited

INDUSTRY

NCT01404169 - 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 | Biotech Hunter | Biotech Hunter