Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408525
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2006-12-05
Brief Title:
Donepezil and Brain Activity Patterns in Those at Risk For Alzheimers Disease
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Efficacy of Donepezil in Normalizing Brain Activation Patterns in People Genetically at Risk for Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to examine patterns of brain activity in people who are at risk for memory problems eg Alzheimers disease or dementiabefore 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 Alzheimers disease
Donepezil is not FDA approved for healthy volunteers and is therefore considered investigational in this study
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 Alzheimers disease
Donepezil is not FDA approved for healthy volunteers and is therefore considered investigational in this study
Detailed Description:
HYPOTHESIS
1 Cognitively intact individuals with normal brain morphology at genetic risk for developing Alzheimers 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 Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None