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

Study Timeline

• Study Start: 2004-06
• Study Completion: 2007-01
• Study First Submitted: 2007-06-05
• Study First Submitted QC: 2007-06-05
• Study First Posted: 2007-06-06
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-01
• Last Update Posted: 2008-02-05

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

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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

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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).

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Albany, New York, United States