- ICH GCP
- US Clinical Trials Registry
- 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
March 7, 2017 updated by: Eisai Limited
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
260
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nanchang, China
- The Second Affiliated Hospital to Nanchang University
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Nanjing Jiangsu, China
- Nanjing Brain Hospital
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Tianjin, China
- Tianjin People's Hospital
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Tianjin, China
- Tianjin Anding Hospital
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Beijing
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Beijing, Beijing, China
- Chinese PLA General hospital
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Beijing, Beijing, China
- Beijing Hospital
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Beijing, Beijing, China
- Xuanwu Hospital Capital Medical University
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Beijing, Beijing, China
- Beijing Huilongguan Hospital
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Beijing, Beijing, China
- Beijing Anding Hospital
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Chongqing
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Chongqing, Chongqing, China
- The First Affiliated Hospital of Chongqing Medical University
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Chongqing, Chongqing, China
- The Second Affiliated Hospital of Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, China
- Guangzhou First People's Hospital
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Guangzhou, Guangdong, China
- Guangzhou Brain Hospital
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Guangxi
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Nanning, Guangxi, China
- The People's Hospital of Guangxi Zhuang Autonomous Region
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Hubei
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Wuhan, Hubei, China
- Tongji Hospital, Tongji Medical College of HUST
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Wuhan, Hubei, China
- Union Hospital, Tongji Medical College Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, China
- The Third Xiangya Hospital of Central South University
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Yueyang, Hunan, China
- The First People's Hospital of Yueyang
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Shandong
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Jinan, Shandong, China
- Qilu Hospital of Shandong University
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Jinan, Shandong, China
- The Second Hospital of Shandong University
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Qingdao, Shandong, China
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai
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Shanghai, Shanghai, China
- Shanghai Ruijin Hospital
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Shanghai, Shanghai, China
- Shanghai Changzheng Hospital
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Shanghai, Shanghai, China
- Renji Hospital, Shanghai Jiaotong University School of Medicine
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Shanghai, Shanghai, China
- Hushan Hospital affliated to Fudan University
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Shanxi
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Xi'An, Shanxi, China
- Tangdu Hospital, The Fourth Military Medical University
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Xi'An, Shanxi, China
- Xi'an Mental Health Center
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Xi'An, Shanxi, China
- Xijing Hospital, the Fourth Military Medical University
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Sichuan
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Chengdu, Sichuan, China
- West China Hospital, Sichuan University
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Chengdu, Sichuan, China
- Sichuan Provincial People's Hospital
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Yunnan
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Kunming, Yunnan, China
- First Affiliated Hospital of Kunming Medical University
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Zhejiang
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Hangzhou, Zhejiang, China
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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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.
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Placebo Comparator: 2
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Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in the total Severe Impairment Battery (SIB) score at Week 24
Time Frame: 24 weeks
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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.
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24
Time Frame: 24 weeks
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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.
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Naoki Kubota, Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2011
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
July 26, 2011
First Submitted That Met QC Criteria
July 26, 2011
First Posted (Estimate)
July 27, 2011
Study Record Updates
Last Update Posted (Actual)
March 8, 2017
Last Update Submitted That Met QC Criteria
March 7, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Dementia
- Alzheimer Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- E2020-C086-339
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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