MR Elastography of Cognitive Impairment

Magnetic Resonance Elastography of Cognitive Impairment

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Healthy; Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected from Mayo Alzheimer's Disease Research Center.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shear Stiffness	Brain stiffness measured by the magnetic resonance elastography (MRE) reported in Kilopascal (kPa)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint mechanical-diffusion	MRE-based measurement of white matter regions of the brain	Baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: John Huston, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography; Elasticity Imaging Techniques
• Other Study ID Numbers: 23-004125; R01AG076636 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No