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Donepezil and Brain Activity Patterns in Those at Risk For Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00408525
Recruitment Status : Unknown
Verified March 2011 by Vanderbilt University.
Recruitment status was:  Recruiting
First Posted : December 7, 2006
Last Update Posted : March 16, 2011
Information provided by:

Study Description
Brief Summary:

The purpose of the study is to examine patterns of brain activity in people who are at risk for memory problems (e.g., Alzheimer's disease or dementia)before and after the medication donepezil. Although genetic testing will be done, the results will not be shared with study participants.

Once the genetic testing is completed subjects may continue to the second phase of the study. During this time they will be asked to take the medication donepezil (which is approved by the FDA for the treatment of Alzheimer's disease).

Donepezil is not FDA approved for healthy volunteers and is therefore considered investigational in this study.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: donepezil Phase 1 Phase 2

Detailed Description:


  1. Cognitively intact individuals with normal brain morphology at genetic risk for developing Alzheimer's' Disease (AD) show alterations in brain activation patterns during tasks that require memory compared to similar individuals with lower risk for developing AD.
  2. Donepezil, a cholinesterase inhibitor, can normalize such brain activation patterns in subjects at risk for AD.


  1. To replicate a recent study1, and compare brain activation in subjects genetically at risk for AD (carriers of the є4 allele of the apolipoprotein E gene (APOE)) with subjects at lower risk for AD (lacking the є4 allele) during tasks that require memory, via functional magnetic resonance imaging (fMRI).
  2. To determine if administration of a drug currently indicated in the treatment of AD, donepezil, can reverse fMRI brain activation patterns of at risk subjects to patterns similar to those of subjects at lower genetic risk for AD.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Efficacy of Donepezil in Normalizing Brain Activation Patterns in People Genetically at Risk for Alzheimer's Disease
Study Start Date : December 2006
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Drug: donepezil
donepezil 5 mg tablets, total dose per day 10 mg for 6 week duration of study. Taken once per day.
Other Name: Aricept

Outcome Measures

Primary Outcome Measures :
  1. Changes in brain activation patterns as measured in an fMRI. [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects may report experiencing subjective memory dysfunction, however they must be found by clinical evaluation to have no memory dysfunction
  • Neuropsychological test battery in the normal range
  • Ages 40-85

Exclusion Criteria:

  • Dementia (Mini-Mental State Exam less than 25/30)
  • Left-handedness
  • Current medication that could influence cognition
  • Medical, psychiatric, and neurologic conditions, including cerebrovascular disease or uncontrolled hypertension
  • Claustrophobia
  • Surgical clips or implants
  • Pacemakers or other implanted electronic devices
  • History of sheet metal work
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00408525

Contact: Barbee Smith, B.A. 615-343-2009 barbee.smith@vanderbilt.edu

United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Barbee Smith, B.A.    615-343-2009    barbee.smith@vanderbilt.edu   
Principal Investigator: Harry E Gwirtsman, M.D.         
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Harry E Gwirtsman, M.D. Vanderbilt University Medical Center
More Information


Responsible Party: Barbee Smith, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00408525     History of Changes
Other Study ID Numbers: 040686
First Posted: December 7, 2006    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011

Keywords provided by Vanderbilt University:
memory loss
memory problems

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