Trial record 1 of 1 for:    01615666
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A Composite MR Neuroimaging Marker for Alzheimer's Disease

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shi-Jiang Li, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01615666
First received: June 6, 2012
Last updated: September 12, 2013
Last verified: September 2013

June 6, 2012
September 12, 2013
March 2009
March 2014   (final data collection date for primary outcome measure)
To determine the sensitivity and specificity of the MRN Index as an AD biomarker. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01615666 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Composite MR Neuroimaging Marker for Alzheimer's Disease
A Composite MR Neuroimaging Marker for Alzheimer's Disease

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.

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).

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Buccal (cheek) swab

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
  • Alzheimer's Disease
  • Mild Cognitive Impairment
  • Frontotemporal Dementia
Not Provided
  • Healthy volunteers
  • Alzheimer's disease
  • Non-Alzheimer's dementia
  • Amnestic mild cognitive impairment
  • Nonamnestic mild cognitive impairment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
380
Not Provided
March 2014   (final data collection date for primary outcome measure)

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
Both
50 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01615666
2R01AG020279-06A2, 2R01AG020279-06A2
No
Shi-Jiang Li, Medical College of Wisconsin
Medical College of Wisconsin
National Institute on Aging (NIA)
Principal Investigator: Shi-Jiang Li, PhD Medical College of Wisconsin
Medical College of Wisconsin
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP