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Home » Clinical Trials » Dementia

Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating E2020 and Placebo for the treatment of Alzheimer's Type Dementia

Research Study Title

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

Purpose

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.

To Learn more
Phase

3

Gender

Both Male and Female

Age

50 to 90 Years

Overall Status

Recruiting

Lead Sponsor

Eisai Limited

Duration

35 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 50 Years to 90 Years

Inclusion Criteria

  • Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.

  • Subject age range: male and female subjects 50 to 90 years of age, inclusive

  • Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

  • MMSE 1 to 12 inclusive, at both Screening and Baseline SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline

  • Comorbid medical conditions must be clinically stable prior to Baseline, unless otherwise specified.

Exclusion Criteria

  • Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD

  • Evidence of focal disease to account for dementia on any cranial image MRI or CT.

  • Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria

  • Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed

  • Illiteracy prior to AD

  • Subjects who are unwilling or unable to fulfill the requirements of the study

  • Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening

  • Subjects with a poor response (tolerability) to prior exposure to donepezil

Site Locations (32)

Country State City Zip Facility and Contact
China Beijing Beijing Xuanwu Hospital Capital Medical University

Ping Jian Jia
Principal Investigator
China Beijing Beijing Chinese PLA General Hospital

Xi Zhang
Principal Investigator
China Beijing Beijing Beijing Huilongguan Hospital

Lan Shang
Principal Investigator
China Beijing Beijing Beijing Anding Hospital

Xian Pei Mao
Principal Investigator
China Beijing Beijing Beijing Hospital

Tao Dan Peng
Principal Investigator
China Chongqing Chongqing The Second Affiliated Hospital of Chongqing Medical University

Mei Yang Chen
Principal Investigator
China Chongqing Chongqing The First Affiliated Hospital of Chongqing Medical University

Yong Yan
Principal Investigator
China Guangdong Guangzhou Guangzhou First People's Hospital

Ping Xiao Pan
Principal Investigator
China Guangdong Guangzhou Guangzhou Brain Hospital

Ni Mo Tang
Principal Investigator
China Guangxi Nanning The People's Hospital of Guangxi Zhuang Autonomous Region

Li Chang Li
Principal Investigator
China Hubei Wuhan Tongji Hospital, Tongji Medical College of HUST

Hua Rong Tang
Principal Investigator
China Hubei Wuhan Union Hospital, Tongji Medical college Huazhong University of Science and Technology

Gang Sheng Sun
Principal Investigator
China Hunan Changsha The Third Xiangya Hospital of Central South University

Yun Qiu Tu
Principal Investigator
China Hunan Yueyang The First People's Hospital of YueYang

Qing Lou Li
Principal Investigator
China Shandong Jinan The Second Hospital of Shandong University

Zhong JIan Bi
Principal Investigator
China Shandong Jinan Qilu Hospital of Shandong University

Zhu Chuan Yan
Principal Investigator
China Shandong Qingdao The Affiliated Hospital of Medical College Qingdao University

Liang Ren Zhao
Principal Investigator
China Shanghai Shanghai Shanghai Ruijin Hospital

Di Sheng Chen
Principal Investigator
China Shanghai Shanghai Shanghai Changzheng Hospital

Xin Zhong Zhao
Principal Investigator
China Shanghai Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Sheng Yan Li
Principal Investigator
China Shanghai Shanghai Hushan Hospital affliated to Fudan University

Zhen Hong
Principal Investigator
China Shanxi Xi'An Xijing Hospital, The Fourth Military Medical University

Gang Zhao
Principal Investigator
China Shanxi Xi'An Tangdu Hospital, The Fourth Military Medical University

Hong Lin
Principal Investigator
China Shanxi Xi'An Xi'An Mental Health Center

Guo Jian Shi
Principal Investigator
China Sichuan Chengdu Sichuan Provincial People's Hospital

Jun Xiao
Principal Investigator
China Sichuan Chengdu West China Hospital, Sichuan University

Bo Yan
Principal Investigator
China Yunnan Kunming First Affiliated Hospital of Kunming Medical University

Feng Xiu Xu
Principal Investigator
China Zhejiang Hangzhou The Second Affiliated hospital of Zhejiang University School of Medicine

Rong Bao Zhang
Principal Investigator
China Nanchang Jiangsi The Second Affiliated Hospital to Nanchang University

Dong Wei Wang
Principal Investigator
China Nanjing Jiangsu Nanjing Brain Hospital

Lin Hai Li
Principal Investigator
China Tianjin Tianjin Anding Hospital

Ying Hong Li
Principal Investigator
China Tianjin Tianjin People's Hospital

Yun Mei Zhang
Principal Investigator

Contact

Customer Joy Department. EJ

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01404169

Date Last Changed: November 11, 2013

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