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
This study is currently recruiting participants.
Verified November 2013 by Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
First received: July 26, 2011
Last updated: November 11, 2013
Last verified: November 2013
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
MedlinePlus related topics: Alzheimer's Disease Brain Diseases Degenerative Nerve Diseases Delirium Dementia Mental Disorders Neurologic DiseasesU.S. FDA Resources
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- The change in the total Severe Impairment Battery (SIB) score at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404169
Show 32 Study Locations
|Contact: Customer Joy Department. EJ||_ML_CLNCL@hhc.eisai.co.jp|
Show 32 Study Locations
Sponsors and Collaborators
|Study Director:||Naoki Kubota||Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.|