A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI
Not Applicable
Completed
- Conditions
- Alzheimer's Disease
- Registration Number
- NCT00483028
- Lead Sponsor
- Pfizer
- Brief Summary
To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing (NPT) and brain Proton Magnetic Resonance Spectroscopy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does donepezil target in mild cognitive impairment as studied in NCT00483028?
How does donepezil's efficacy in MCI compare to standard-of-care cholinesterase inhibitors like rivastigmine?
Which biomarkers were used in NCT00483028 to assess donepezil's impact on brain metabolism in MCI patients?
What adverse events were reported in NCT00483028 and how do they align with donepezil's known safety profile?
Are there combination therapies involving donepezil that show improved outcomes for Alzheimer's-related MCI patients?
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Albany, New York, United States
Pfizer Investigational Site🇺🇸Albany, New York, United States