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

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00293176

Enrollment

821

Registered

2006-02-17

Start date

2003-12-31

Completion date

2007-03-31

Last updated

2011-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Memory Loss

Keywords

Cognitive impairment, Memory Loss

Brief summary

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

Interventions

DRUGDonepezil 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.

DRUGPlacebo

Subjects will receive matching placebo tablets.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

45 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Assessment of cognitive and global function in subjects with MCI.	—

Secondary

Measure	Time frame
Behavioral, global and cognitive outcomes; Neuroimaging	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026