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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00483028
First received: June 5, 2007
Last updated: February 1, 2008
Last verified: February 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

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

Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013