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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00408525
First received: December 5, 2006
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: donepezil
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Changes in brain activation patterns as measured in an fMRI. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Donepezil
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

Detailed Description:

HYPOTHESIS

  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.

SPECIFIC AIMS

  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.
  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408525

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

Locations
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
Investigators
Principal Investigator: Harry E Gwirtsman, M.D. Vanderbilt University
  More Information

Publications:

Responsible Party: Barbee Smith, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00408525     History of Changes
Other Study ID Numbers: 040686
Study First Received: December 5, 2006
Last Updated: March 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
memory loss
memory problems
alzheimer's
forgetfulness
forgetting

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

ClinicalTrials.gov processed this record on November 20, 2014