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

February 1, 2018 updated by: Vanderbilt University

Efficacy of Donepezil in Normalizing Brain Activation Patterns in People Genetically at Risk for Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in brain activation patterns as measured in an fMRI.
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Harry E Gwirtsman, M.D., Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

August 24, 2012

Study Completion (Actual)

August 24, 2012

Study Registration Dates

First Submitted

December 5, 2006

First Submitted That Met QC Criteria

December 6, 2006

First Posted (Estimate)

December 7, 2006

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 040686

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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