- 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
- 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