Back to resultsA Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
donezepil (Aricept)
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00483028
Brief Title
A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI
Official Title
A Randomized Double-Blind, Parallel, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil (5 mg QD for 6 Weeks) After Single Dose and Steady State Therapy (2 Weeks and 6 Weeks) in Subjects With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing (NPT) and brain Proton Magnetic Resonance Spectroscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
38 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
donezepil (Aricept)
Primary Outcome Measure Information:
Title
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.)
Title
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Pfizer Investigational Site
City
Albany
State/Province
New York
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001134&StudyName=A+Randomized%2C+Placebo%2DControlled+Trial+to+Examine+the+Efficacy+of+Oral+Donepezil+in+subjects+with+MCI
Description
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Learn more about this trial
A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI
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