MR Elastography of Cognitive Impairment

• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Healthy
• Interventions: Diagnostic Test: Magnetic Resonance Elastography (MRE)

• Registration Number: NCT06029114
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Study Start: 2023-10-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2027-11
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Control Group	Magnetic Resonance Elastography (MRE)	Subjects will have a magnetic resonance elastography (MRE) performed.
Mild Cognitive Impairment Group	Magnetic Resonance Elastography (MRE)	Subjects will have a magnetic resonance elastography (MRE) performed.
Alzheimer's Disease Group	Magnetic Resonance Elastography (MRE)	Subjects will have a magnetic resonance elastography (MRE) performed.

Primary Outcome Measures

Name	Time	Method
Shear Stiffness	Baseline	Brain stiffness measured by the magnetic resonance elastography (MRE) reported in Kilopascal (kPa)

Secondary Outcome Measures

Name	Time	Method
Joint mechanical-diffusion	Baseline	MRE-based measurement of white matter regions of the brain

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States