Donepezil and Brain Activity Patterns in Those at Risk For Alzheimer's Disease
| Status: | Completed |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 40 - 85 |
| Updated: | 2/7/2018 |
| Start Date: | December 2006 |
| End Date: | August 24, 2012 |
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.
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.
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.
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.
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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials
