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

Pfizer

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Drug: donezepil (Aricept)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483028

A9001134

Details and patient eligibility

About

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

Sex: All

Ages: 55 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind