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
|ClinicalTrials.gov Identifier: NCT01404169|
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : March 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Type Dementia||Drug: E2020 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||September 2011|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||September 2014|
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.
|Placebo Comparator: 2||
Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.
- The change in the total Severe Impairment Battery (SIB) score at Week 24 [ Time Frame: 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.
- Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404169
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|Study Director:||Naoki Kubota||Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.|