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

A Randomized Double-Blind, Parallel, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil (5 mg QD for 6 Weeks) After Single Dose and Steady State Therapy (2 Weeks and 6 Weeks) in Subjects With Mild Cognitive Impairment

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

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