A Composite MR Neuroimaging Marker for Alzheimer's Disease

Medical College of Wisconsin

Status: Withdrawn

Conditions: Alzheimer's Disease; Frontotemporal Dementia; Mild Cognitive Impairment

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01615666

2R01AG020279-06A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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:

1. The fMRI index will differentiate between Alzheimer's disease, non-Alzheimer's dementia, and healthy volunteers;
2. 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;
3. 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.

Full 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).

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 5 patient groups

Healthy volunteers

Description:

Healthy volunteers who will undergo functional MRI (fMRI) to obtain fMRI index

Alzheimer's disease

Description:

Individuals with Alzheimer's disease who will undergo functional MRI (fMRI) to obtain fMRI index

Non-Alzheimer's dementia

Description:

Individuals with Non-Alzheimer's dementia who will undergo functional MRI (fMRI) to obtain fMRI index

Amnestic mild cognitive impairment

Description:

Individuals with Amnestic mild cognitive impairment who will undergo functional MRI (fMRI) to obtain fMRI index

Nonamnestic mild cognitive impairment

Description:

Individuals with Nonamnestic mild cognitive impairment who will undergo functional MRI (fMRI) to obtain fMRI index