MR Elastography of Cognitive Impairment

NCT06029114 | Enrolling By Invitation

• 2 other identifiers: 23-004125R01AG076636
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Alzheimer Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Shear Stiffness

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

  Baseline

Secondary Outcomes (1)

• Joint mechanical-diffusion

  Baseline

Study Arms (3)

Healthy Control Group

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

Diagnostic Test: Magnetic Resonance Elastography (MRE)

Alzheimer's Disease Group

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

Diagnostic Test: Magnetic Resonance Elastography (MRE)

Mild Cognitive Impairment Group

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

Diagnostic Test: Magnetic Resonance Elastography (MRE)

Interventions

Magnetic Resonance Elastography (MRE) DIAGNOSTIC_TEST

Imaging technique performed on a Compact 3T MRI scanner that measures the stiffness (mechanical properties) of tissues.

Alzheimer's Disease Group; Healthy Control Group; Mild Cognitive Impairment Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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
• In good general health

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• John Huston, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: October 11, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)