Alzheimer DiseaseNCT06029114
MR Elastography of Cognitive Impairment
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to further investigate the potential of brain stiffness as a novel biomarker for Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Healthy
- What is being tested?
- Magnetic Resonance Elastography (MRE)
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2023to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be selected from Mayo Alzheimer's Disease Research Center.
Who may be able to join
- 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
Show all 19Show fewer
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Healthy
- Being tested
- Magnetic Resonance Elastography (MRE)
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Elastography (MRE)Diagnostic test
Imaging technique performed on a Compact 3T MRI scanner that measures the stiffness (mechanical properties) of tissues.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group | Subjects will have a magnetic resonance elastography (MRE) performed. Receives: Diagnostic Test: Magnetic Resonance Elastography (MRE) | |
| Alzheimer's Disease Group | Subjects will have a magnetic resonance elastography (MRE) performed. Receives: Diagnostic Test: Magnetic Resonance Elastography (MRE) | |
| Mild Cognitive Impairment Group | Subjects will have a magnetic resonance elastography (MRE) performed. Receives: Diagnostic Test: Magnetic Resonance Elastography (MRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear Stiffness
Brain stiffness measured by the magnetic resonance elastography (MRE) reported in Kilopascal (kPa)
Measured: Baseline
Secondary outcomes (1)
Joint mechanical-diffusion
MRE-based measurement of white matter regions of the brain
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start11 Oct 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, John Huston, Mayo Clinic
- Investigators
- John Huston, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029114
- Sponsor's protocol ID
- 23-004125
- Other IDs
- R01AG076636
- Status last verified
- Jan 2026
- First submitted
- 1 Sep 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Elastography of Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06029114
- Acronym / sponsor ID
- 23-004125
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Healthy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | – | Diagnostic Test: Magnetic Resonance Elastography (MRE)Subjects will have a magnetic resonance elastography (MRE) performed. |
| Alzheimer's Disease Group | – | Diagnostic Test: Magnetic Resonance Elastography (MRE)Subjects will have a magnetic resonance elastography (MRE) performed. |
| Mild Cognitive Impairment Group | – | Diagnostic Test: Magnetic Resonance Elastography (MRE)Subjects will have a magnetic resonance elastography (MRE) performed. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from Mayo Alzheimer's Disease Research Center.
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Elastography (MRE)Imaging technique performed on a Compact 3T MRI scanner that measures the stiffness (mechanical properties) of tissues. | Diagnostic test | Alzheimer's Disease Group, Healthy Control Group, Mild Cognitive Impairment Group |
Primary outcome
Shear Stiffness
Time frame: Baseline
Brain stiffness measured by the magnetic resonance elastography (MRE) reported in Kilopascal (kPa)
1 secondary outcome
Joint mechanical-diffusion
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Huston, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear Stiffness (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.