The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
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|ClinicalTrials.gov Identifier: NCT00293176|
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : April 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Memory Loss||Drug: Donepezil Hydrochloride Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||821 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2007|
Drug: Donepezil Hydrochloride
Subects will receive a starting dose of 5 mg orally. Dose-escalation from 5 mg to 10 mg will occur at the Week 9 Visit.
|Placebo Comparator: 2||
Subjects will receive matching placebo tablets.
- Assessment of cognitive and global function in subjects with MCI.
- Behavioral, global and cognitive outcomes; Neuroimaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293176
Show 54 Study Locations
|Study Director:||Anita Murthy||Eisai Inc.|