The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)

Memory Loss Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293176
• Other study ID #: E2020-A001-412
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2006
• Last updated: March 31, 2011
• Start date: December 2003
• Est. completion date: March 2007

Study information

• Verified date: March 2011
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.

Other known NCT identifiers

• NCT00100022

Recruitment information / eligibility

• Status: Completed
• Enrollment: 821
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amnesia
• Cognition Disorders
• Memory Loss
• Mild Cognitive Impairment

Intervention

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
Subjects will receive matching placebo tablets.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of cognitive and global function in subjects with MCI.
Secondary	Behavioral, global and cognitive outcomes; Neuroimaging