A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-01-31

Brief Summary

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To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing (NPT) and brain Proton Magnetic Resonance Spectroscopy.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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donezepil (Aricept)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males or females ages 55-90 inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead ECG and clinical laboratory tests)
* Body Mass Index (BMI) between 18 to 34 kg/m2, inclusive; and a total body weight
* Subjects with mild cognitive impairment (MCI) must have a reliable informant who has an average of 10 hours per week or more contact with the subject.
* Memory complaints and memory difficulties, which are verified by an informant
* Mini-mental status exam (MMSE) score of 24-30

Exclusion Criteria

* Subjects with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives
* Insulin-requiring diabetes or uncontrolled diabetes mellitus
* Subjects with a current diagnosis of depression or other psychiatric illnesses

Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes