A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: June 5, 2007
Last updated: February 1, 2008
Last verified: February 2008
To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing (NPT) and brain Proton Magnetic Resonance Spectroscopy.

Condition Intervention
Alzheimer's Disease
Drug: donezepil (Aricept)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

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).

Estimated Enrollment: 38
Study Start Date: June 2004
Study Completion Date: January 2007

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00483028

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States
United States, New York
Pfizer Investigational Site
Albany, New York, United States
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00483028     History of Changes
Other Study ID Numbers: A9001134 
Study First Received: June 5, 2007
Last Updated: February 1, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 26, 2016