MR Elastography of Cognitive Impairment

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06029114
Collaborator
National Institute on Aging (NIA) (NIH)
450
1
50
9

Study Details

Study Description

Brief Summary

The purpose of this research is to further investigate the potential of brain stiffness as a novel biomarker for Alzheimer's disease.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Magnetic Resonance Elastography (MRE)

Detailed Description

Due to shifting demographics, the prevalence of dementia continues to increase in the population. To mitigate the effects of dementia will require new treatments working jointly with new methods for earlier and more sensitive diagnosis of the diseases. Magnetic resonance elastography (MRE) is a noninvasive technique for measuring tissue stiffness. MRE is a three-step process beginning with the introduction of shear waves into the tissue of interest with an external vibration source. The shear waves are imaged with a phase-contrast MRI pulse sequence and the resulting wave images are mathematically inverted to calculate tissue stiffness.

Preliminary data indicate that global brain stiffness is highly reproducible and that Alzheimer's disease causes a decrease in brain stiffness when compared to age- and gender-matched cognitively normal controls. The purpose of the proposed work is to further investigate the potential of brain stiffness as a novel biomarker for Alzheimer's disease. A comparison between brain stiffness and existing Alzheimer's disease biomarkers will help determine the biological basis of the observed stiffness change and in time may improve the sensitivity of Alzheimer's disease diagnosis and grading.

Study Design

Study Type:
Observational
Anticipated Enrollment :
450 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Magnetic Resonance Elastography of Cognitive Impairment
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2027
Anticipated Study Completion Date :
Nov 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Healthy Control Group

Subjects will have a magnetic resonance elastography (MRE) performed.

Diagnostic Test: Magnetic Resonance Elastography (MRE)
Imaging technique performed on a Compact 3T MRI scanner that measures the stiffness (mechanical properties) of tissues.

Alzheimer's Disease Group

Subjects will have a magnetic resonance elastography (MRE) performed.

Diagnostic Test: Magnetic Resonance Elastography (MRE)
Imaging technique performed on a Compact 3T MRI scanner that measures the stiffness (mechanical properties) of tissues.

Mild Cognitive Impairment Group

Subjects will have a magnetic resonance elastography (MRE) performed.

Diagnostic Test: Magnetic Resonance Elastography (MRE)
Imaging technique performed on a Compact 3T MRI scanner that measures the stiffness (mechanical properties) of tissues.

Outcome Measures

Primary Outcome Measures

  1. Shear Stiffness [Baseline]

    Brain stiffness measured by the magnetic resonance elastography (MRE) reported in Kilopascal (kPa)

Secondary Outcome Measures

  1. Joint mechanical-diffusion [Baseline]

    MRE-based measurement of white matter regions of the brain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria for Control Subjects:
  • In good general health

  • No Active neurological or psychiatric conditions, if a prior neurological or psychiatric condition was present they must have returned to normal

  • No cognitive complaints

  • Normal neurological examination

  • No psychoactive medications

  • They may have a chronic medical condition that does not affect cognition

  • Low Aβ load Pittsburgh compound-B (PiB) ratio <1.5

Inclusion Criteria for Mild Cognitive Impairment Subjects:
  • In good general health

  • Memory complaint documented by the patient and collateral source

  • Normal general cognitive function as determined by measure of general intellectual function and screening including the Short Test of Mental Status

  • Normal activities of daily living as documented by history and Record of Independent Living

  • Not demented by DSM-III-R criteria

  • Do have an objective memory impairment determined by the clinical judgement of the neuropsychologists and neurologists

  • High Aβ load Pittsburgh compound-B (PiB) ratio ≥1.5

Inclusion Criteria for Alzheimer's Disease Subjects:
  • In good general health

  • Dementia not a result of other medical or psychiatric conditions

  • Diagnosis of dementia made according to DSM-III-R criteria

  • Do have objective memory impairment determined by the clinical judgement of the neuropsychologists and neurologists

  • High Aβ load Pittsburgh compound-B (PiB) ratio ≥1.5

Exclusion Criteria:
  • Alzheimer's disease or mild cognitive impairment due to a known genetic mutation

  • Major depression

  • History of primary or metastatic intracranial neoplasm, significant head trauma, intra-cerebral hemorrhage, hemispheric stroke

  • Contradictions to MRI imaging including but not limited to cardiac pacemakers, intraocular or intracranial metal, or other MRI incompatible devices.

  • Pregnant women. Women of child bearing potential will be given a urine pregnancy test prior the MRI scan. Results will be shared with the participant. If the pregnancy test is positive, the participant will not be included within the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Minnesota Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • National Institute on Aging (NIA)

Investigators

  • Principal Investigator: John Huston, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
John Huston, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT06029114
Other Study ID Numbers:
  • 23-004125
  • R01AG076636
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2023