Status:
COMPLETED
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
Lead Sponsor:
Eisai Limited
Conditions:
Alzheimer's Type Dementia
Eligibility:
All Genders
50-90 years
Phase:
PHASE3
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
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT01404169
Start Date
September 1 2011
End Date
September 1 2014
Last Update
March 8 2017
Active Locations (32)
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1
Beijing Anding Hospital
Beijing, Beijing Municipality, China
2
Beijing Hospital
Beijing, Beijing Municipality, China
3
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, China
4
Chinese PLA General Hospital
Beijing, Beijing Municipality, China