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
  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:

  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.

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

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • To determine the sensitivity and specificity of the MRN Index as an AD biomarker. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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
Study Population
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615666

Locations
United States, Wisconsin
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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: September 12, 2013
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
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 14, 2014