A Composite MR Neuroimaging Marker for Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT01615666|
Recruitment Status : Withdrawn (This was never a clinical trial and should never have been approved.)
First Posted : June 8, 2012
Last Update Posted : January 14, 2016
The purpose of this study is to use a functional MRI (fMRI) index to compare the brain activity of healthy volunteers to that of people with mild cognitive impairment (MCI) and Alzheimer's disease. The ultimate goal is to develop an early diagnostic tool for Alzheimer's disease.
The study hypotheses are:
- The fMRI index will differentiate between Alzheimer's disease, non-Alzheimer's dementia, and healthy volunteers;
- The fMRI index will distinguish participants with MCI who convert to Alzheimer's disease from those who convert to a non-Alzheimer's dementia and those who remain stable;
- MCI participants with a lower fMRI index at baseline who convert will progress to Alzheimer's sooner than those with a higher fMRI index, and MCI participants with a faster rate of fMRI index decline who convert will have an earlier onset of Alzheimer's disease.
|Condition or disease|
|Alzheimer's Disease Mild Cognitive Impairment Frontotemporal Dementia|
The onset of Alzheimer's disease is insidious and the boundary between normal aging and Alzheimer's disease is blurred. In order to prevent and treat Alzheimer's disease, the investigators must be able to mark its preclinical stage, before brain damage becomes irreversible. There is a substantial body of research dealing with predictive markers of Alzheimer's disease in individuals with mild cognitive impairment (MCI). Despite these advances, however, researchers have not had enough evidence to recommend specific techniques that mark preclinical Alzheimer's disease. This new functional MRI (fMRI) index may fill this gap.
Participants will have two visits, one for memory testing and neurological examination, and one for an MRI scan. Each visit will take approximately 1½ hours. For volunteers who wish to do so, all study procedures may be completed in a single visit. Participants with MCI will be followed annually.
The investigators are currently enrolling healthy volunteers, as well as individuals with MCI (memory loss that does not significantly affect normal daily activities), Alzheimer's disease, and frontotemporal dementia (includes primary progressive aphasia).
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Observational Model:||Case Control|
|Official Title:||A Composite MR Neuroimaging Marker for Alzheimer's Disease|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Healthy volunteers who will undergo functional MRI (fMRI) to obtain fMRI index
Individuals with Alzheimer's disease who will undergo functional MRI (fMRI) to obtain fMRI index
Individuals with Non-Alzheimer's dementia who will undergo functional MRI (fMRI) to obtain fMRI index
Amnestic mild cognitive impairment
Individuals with Amnestic mild cognitive impairment who will undergo functional MRI (fMRI) to obtain fMRI index
Nonamnestic mild cognitive impairment
Individuals with Nonamnestic mild cognitive impairment who will undergo functional MRI (fMRI) to obtain fMRI index
- To determine the sensitivity and specificity of the MRN Index as an AD biomarker. [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
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): NCT01615666
|United States, Wisconsin|
|Medical College of Wisconsin/Froedtert Hospital|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Shi-Jiang Li, PhD||Medical College of Wisconsin|