Donepezil and Brain Activity Patterns in Those at Risk For Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT00408525|
Recruitment Status : Completed
First Posted : December 7, 2006
Last Update Posted : February 5, 2018
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|
- 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.
- Donepezil, a cholinesterase inhibitor, can normalize such brain activation patterns in subjects at risk for AD.
- 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).
- 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 (Clinical Trial)|
|Actual Enrollment :||41 participants|
|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|
|Actual Primary Completion Date :||August 24, 2012|
|Actual Study Completion Date :||August 24, 2012|
U.S. FDA Resources
donepezil 5 mg tablets, total dose per day 10 mg for 6 week duration of study. Taken once per day.
Other Name: Aricept
- Changes in brain activation patterns as measured in an fMRI. [ Time Frame: 8 weeks ]
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
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Harry E Gwirtsman, M.D.||Vanderbilt University Medical Center|