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

Completed · Not applicable

Conditions studied: Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT00483028

Run by

Pfizer

People needed

38

Starts

2004-06-01

Expected to finish

2007-01-01

Last updated by the study team

2008-02-05

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States
• Pfizer Investigational Site — Albany, New York, United States

Full record on ClinicalTrials.gov

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