Alzheimer's Disease
Conditions
Brief summary
To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing (NPT) and brain Proton Magnetic Resonance Spectroscopy.
Interventions
DRUGdonezepil (Aricept)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropsychologic test scores: GMLT, DSST, Cog State TM including PAL test, RAVLT, ADAS-cog at baseline (pre-dose) 5 and 8 hours after the first dose and 2 and 6 weeks. (Continues in next bullet.) | — |
| MRS (Magnetic Resonance Spectroscopy) profile including but not limited to NAA (N-acetyl-aspartate), NAA/Cr (N-acetyl-aspartate/creatinine ratio), MI (Myoinositol) and MI/Cr (Myoinositol/creatinine ratio). | — |
Countries
United States
Outcome results
None listed