Status:
COMPLETED
The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
Lead Sponsor:
Eisai Inc.
Collaborating Sponsors:
Pfizer
Conditions:
Memory Loss
Eligibility:
All Genders
45-90 years
Phase:
PHASE4
Brief Summary
To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.
Eligibility Criteria
Inclusion
- Memory complaint
- Mini Mental Status Exam (MMSE) score 24-28 inclusive
- General cognition and function performance sufficiently preserved such that a diagnosis of Alzheimer's disease (AD) cannot be made
- Generally healthy and ambulatory
- Sufficiently fluent in English
Exclusion
- Diagnosis of probable or possible AD
- Neurological disorders
- History of malignant cancers
- Previously have taken donepezil or other acetylcholinesterase (ChE) inhibitors for more than 1 month or in the past 3 months prior to study entry
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
821 Patients enrolled
Trial Details
Trial ID
NCT00293176
Start Date
December 1 2003
End Date
March 1 2007
Last Update
April 1 2011
Active Locations (54)
Enter a location and click search to find clinical trials sorted by distance.
1
Albaster, Alabama, United States
2
Mesa, Arizona, United States
3
Peoria, Arizona, United States
4
Sun City, Arizona, United States