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Enrolling by invitation NCT06029114

MR Elastography of Cognitive Impairment

— Observational Alzheimer Disease Mild Cognitive Impairment Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Elastography (MRE).
Who it may be relevant to
Registry conditions: Alzheimer Disease, Mild Cognitive Impairment, Healthy. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Magnetic Resonance Elastography of Cognitive Impairment

Overview

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.

Interventions

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

Primary outcome measures

  • Shear Stiffness [Time frame: Baseline]
Secondary outcome measures (1)
  • Joint mechanical-diffusion [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic Minnesota — Rochester

Identifiers

NCT: NCT06029114 · 23-004125 · R01AG076636

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗