Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Type Dementia
Keywords: Alzheimer Disease
Dementia
Delirium
Amnestic
Cognitive Disorders
Donepezil
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Cholinesterase Inhibitors
Enzy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-27
Enrollment: 260
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The change in the total Severe Impairment Battery (SIB) score at Week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Huilongguan Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Guangzhou Brain Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
state: Hubei
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical college Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Yueyang
country: China
facility: The First People's Hospital of YueYang
state: Hunan
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Medical College Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Hushan Hospital affliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: Xi'An
country: China
facility: Tangdu Hospital, The Fourth Military Medical University
state: Shanxi
city: Xi'An
country: China
facility: Xi'An Mental Health Center
state: Shanxi
city: Xi'An
country: China
facility: Xijing Hospital, The Fourth Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Nanchang
country: China
facility: The Second Affiliated Hospital to Nanchang University
city: Nanjing Jiangsu
country: China
facility: Nanjing Brain Hospital
city: Tianjin
country: China
facility: Tianjin Anding Hospital
city: Tianjin
country: China
facility: Tianjin People's Hospital
Study officials:
affiliation: Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.
name: Naoki Kubota
role: STUDY_DIRECTOR
References: