A Composite MR Neuroimaging Marker for Alzheimer's Disease
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Purpose
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 |
|---|
|
Alzheimer's Disease Mild Cognitive Impairment Frontotemporal Dementia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | A Composite MR Neuroimaging Marker for Alzheimer's Disease |
Buccal (cheek) swab
| Estimated Enrollment: | 380 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Healthy volunteers |
| Alzheimer's disease |
| Non-Alzheimer's dementia |
| Amnestic mild cognitive impairment |
| Nonamnestic mild cognitive impairment |
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
- Alzheimer's, non-Alzheimer's dementia, and mild cognitive impairment (MCI) participants recruited from the Medical College of Wisconsin/Froedtert Hospital Memory Disorders Clinic
- MCI and healthy volunteers recruited from the community
Inclusion Criteria:
- 60 years of age or older (50 years of age or older for frontotemporal dementia patients)
- Normal memory, mild cognitive impairment (memory loss that does not significantly affect normal daily activities), or clinical diagnosis of Alzheimer's disease or frontotemporal dementia (includes primary progressive aphasia)
- Right-handed
- General good physical health
Exclusion Criteria:
- History of stroke or neurological disease (other than Alzheimer's disease or frontotemporal dementia)
- Seizures or head injury with loss of consciousness within the last five years
- Ferrous (magnetic) or electronic implants (due to the magnet in the MRI scanner)
- Claustrophobia
Contacts and Locations| Contact: Jennifer Jones, MS, CCRC | 414-805-5232 | jljones@mcw.edu |
| United States, Wisconsin | |
| Medical College of Wisconsin/Froedtert Hospital | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Sub-Investigator: Piero Antuono, MD | |
| Principal Investigator: | Shi-Jiang Li, PhD | Medical College of Wisconsin |
More Information
No publications provided
| Responsible Party: | Shi-Jiang Li, Professor, Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT01615666 History of Changes |
| Other Study ID Numbers: | 2R01AG020279-06A2, 2R01AG020279-06A2 |
| Study First Received: | June 6, 2012 |
| Last Updated: | June 7, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Medical College of Wisconsin:
|
Alzheimer's disease Mild Cognitive Impairment Frontotemporal dementia |
fMRI functional neuroimaging Memory |
Additional relevant MeSH terms:
|
Alzheimer Disease Pick Disease of the Brain Cognition Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Metabolic Diseases Speech Disorders Language Disorders |
Communication Disorders Dementia Frontotemporal Dementia Aphasia, Primary Progressive Tauopathies Frontotemporal Lobar Degeneration TDP-43 Proteinopathies Proteostasis Deficiencies Aphasia Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013