Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267163
Status:
COMPLETED
Last Update Posted:
2008-08-29
First Post:
2005-12-16
Brief Title:
Brain Imaging and Mental Disorders of Aging Intervention
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Brain Imaging and Mental Disorders of Aging Intervention
Status:
COMPLETED
Status Verified Date:
2008-08
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 goal of this project is to determine if a cholinesterase inhibitor is more effective than placebo in delaying cognitive and brain functional decline in people at risk for Alzheimers disease
Detailed Description:
Studies to date show that pictures of the brain using PET positron emission tomography scan measures predict memory decline in people with genetic risks for developing AD They have also been shown to predict memory decline in people with mild memory complaints These findings are consistent with other evidence that the changes of Alzheimers Disease AD begin years before the doctor can confirm a diagnosis
In this study PET and genetic risk studies will be performed in people with mild memory complaints A total of 138 participants age 40 to 90 years who are at risk for further memory decline will be enrolled They will be randomized like the flip of a coin to one of two treatment groups donepezil a medication to treat mild AD or placebo and followed 18 months for evidence of future decline Participants will receive magnetic resonance imaging MRI scans PET scans genetic risk assessment for Alzheimers Disease and neuropsychological assessments Repeat brain imaging studies will be performed at the end of the 18-month treatment trial
These procedures will allow researchers to explore how baseline brain function and genetic risk for AD onset influences brain metabolic rate and memory decline and treatment outcome Participants receiving donepezil are expected to show less evidence of decline than those receiving placebo This project will expand a growing research program in early detection and prevention of AD designed 1 to identify persons without memory complaints who are most likely to benefit from early intervention and 2 to provide an objective way to monitor the activity in the brain
In this study PET and genetic risk studies will be performed in people with mild memory complaints A total of 138 participants age 40 to 90 years who are at risk for further memory decline will be enrolled They will be randomized like the flip of a coin to one of two treatment groups donepezil a medication to treat mild AD or placebo and followed 18 months for evidence of future decline Participants will receive magnetic resonance imaging MRI scans PET scans genetic risk assessment for Alzheimers Disease and neuropsychological assessments Repeat brain imaging studies will be performed at the end of the 18-month treatment trial
These procedures will allow researchers to explore how baseline brain function and genetic risk for AD onset influences brain metabolic rate and memory decline and treatment outcome Participants receiving donepezil are expected to show less evidence of decline than those receiving placebo This project will expand a growing research program in early detection and prevention of AD designed 1 to identify persons without memory complaints who are most likely to benefit from early intervention and 2 to provide an objective way to monitor the activity in the brain
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 9R01AG018487-06 | NIH | None | httpsreporternihgovquickSearch9R01AG018487-06 |