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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00483028
Recruitment Status : Completed
First Posted : June 6, 2007
Last Update Posted : February 5, 2008
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Brief Summary:
To purpose of this study is to estimate the effect of donepezil on Neuropsychological Testing (NPT) and brain Proton Magnetic Resonance Spectroscopy.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: donezepil (Aricept) Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2004
Actual Study Completion Date : January 2007

Primary Outcome Measures :
  1. 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.)
  2. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Call Center Pfizer

Additional Information: Identifier: NCT00483028     History of Changes
Other Study ID Numbers: A9001134
First Posted: June 6, 2007    Key Record Dates
Last Update Posted: February 5, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents