xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06029114</url>
    </required_header>
    <id_info>
      <org_study_id>23-004125</org_study_id>
      <secondary_id>R01AG076636</secondary_id>
      <nct_id>NCT06029114</nct_id>
    </id_info>
    <brief_title>MR Elastography of Cognitive Impairment</brief_title>
    <official_title>Magnetic Resonance Elastography of Cognitive Impairment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Mayo Clinic</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this research is to further investigate the potential of brain stiffness as a&#xD;
        novel biomarker for Alzheimer's disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Due to shifting demographics, the prevalence of dementia continues to increase in the&#xD;
        population. To mitigate the effects of dementia will require new treatments working jointly&#xD;
        with new methods for earlier and more sensitive diagnosis of the diseases. Magnetic resonance&#xD;
        elastography (MRE) is a noninvasive technique for measuring tissue stiffness. MRE is a&#xD;
        three-step process beginning with the introduction of shear waves into the tissue of interest&#xD;
        with an external vibration source. The shear waves are imaged with a phase-contrast MRI pulse&#xD;
        sequence and the resulting wave images are mathematically inverted to calculate tissue&#xD;
        stiffness.&#xD;
  &#xD;
        Preliminary data indicate that global brain stiffness is highly reproducible and that&#xD;
        Alzheimer's disease causes a decrease in brain stiffness when compared to age- and&#xD;
        gender-matched cognitively normal controls. The purpose of the proposed work is to further&#xD;
        investigate the potential of brain stiffness as a novel biomarker for Alzheimer's disease. A&#xD;
        comparison between brain stiffness and existing Alzheimer's disease biomarkers will help&#xD;
        determine the biological basis of the observed stiffness change and in time may improve the&#xD;
        sensitivity of Alzheimer's disease diagnosis and grading.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2027</completion_date>
    <primary_completion_date type="Anticipated">November 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Shear Stiffness</measure>
      <time_frame>Baseline</time_frame>
      <description>Brain stiffness measured by the magnetic resonance elastography (MRE) reported in Kilopascal (kPa)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Joint mechanical-diffusion</measure>
      <time_frame>Baseline</time_frame>
      <description>MRE-based measurement of white matter regions of the brain</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">450</enrollment>
    <condition>Alzheimer Disease</condition>
    <condition>Mild Cognitive Impairment</condition>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Healthy Control Group</arm_group_label>
      <description>Subjects will have a magnetic resonance elastography (MRE) performed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Alzheimer's Disease Group</arm_group_label>
      <description>Subjects will have a magnetic resonance elastography (MRE) performed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mild Cognitive Impairment Group</arm_group_label>
      <description>Subjects will have a magnetic resonance elastography (MRE) performed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Magnetic Resonance Elastography (MRE)</intervention_name>
      <description>Imaging technique performed on a Compact 3T MRI scanner that measures the stiffness (mechanical properties) of tissues.</description>
      <arm_group_label>Alzheimer's Disease Group</arm_group_label>
      <arm_group_label>Healthy Control Group</arm_group_label>
      <arm_group_label>Mild Cognitive Impairment Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects will be selected from Mayo Alzheimer's Disease Research Center.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria for Control Subjects:&#xD;
  &#xD;
            -  In good general health&#xD;
  &#xD;
            -  No Active neurological or psychiatric conditions, if a prior neurological or&#xD;
               psychiatric condition was present they must have returned to normal&#xD;
  &#xD;
            -  No cognitive complaints&#xD;
  &#xD;
            -  Normal neurological examination&#xD;
  &#xD;
            -  No psychoactive medications&#xD;
  &#xD;
            -  They may have a chronic medical condition that does not affect cognition&#xD;
  &#xD;
            -  Low Aβ load Pittsburgh compound-B (PiB) ratio &lt;1.5&#xD;
  &#xD;
          Inclusion Criteria for Mild Cognitive Impairment Subjects:&#xD;
  &#xD;
            -  In good general health&#xD;
  &#xD;
            -  Memory complaint documented by the patient and collateral source&#xD;
  &#xD;
            -  Normal general cognitive function as determined by measure of general intellectual&#xD;
               function and screening including the Short Test of Mental Status&#xD;
  &#xD;
            -  Normal activities of daily living as documented by history and Record of Independent&#xD;
               Living&#xD;
  &#xD;
            -  Not demented by DSM-III-R criteria&#xD;
  &#xD;
            -  Do have an objective memory impairment determined by the clinical judgement of the&#xD;
               neuropsychologists and neurologists&#xD;
  &#xD;
            -  High Aβ load Pittsburgh compound-B (PiB) ratio ≥1.5&#xD;
  &#xD;
          Inclusion Criteria for Alzheimer's Disease Subjects:&#xD;
  &#xD;
            -  In good general health&#xD;
  &#xD;
            -  Dementia not a result of other medical or psychiatric conditions&#xD;
  &#xD;
            -  Diagnosis of dementia made according to DSM-III-R criteria&#xD;
  &#xD;
            -  Do have objective memory impairment determined by the clinical judgement of the&#xD;
               neuropsychologists and neurologists&#xD;
  &#xD;
            -  High Aβ load Pittsburgh compound-B (PiB) ratio ≥1.5&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Alzheimer's disease or mild cognitive impairment due to a known genetic mutation&#xD;
  &#xD;
            -  Major depression&#xD;
  &#xD;
            -  History of primary or metastatic intracranial neoplasm, significant head trauma,&#xD;
               intra-cerebral hemorrhage, hemispheric stroke&#xD;
  &#xD;
            -  Contradictions to MRI imaging including but not limited to cardiac pacemakers,&#xD;
               intraocular or intracranial metal, or other MRI incompatible devices.&#xD;
  &#xD;
            -  Pregnant women. Women of child bearing potential will be given a urine pregnancy test&#xD;
               prior the MRI scan. Results will be shared with the participant. If the pregnancy test&#xD;
               is positive, the participant will not be included within the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>John Huston, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Timothy Waters</last_name>
      <phone>507-293-0692</phone>
      <email>Waters.Timothy@mayo.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mayo Clinic Minnesota</name>
        <address>
          <city>Rochester</city>
          <state>Minnesota</state>
          <zip>55905</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mayo Clinic</investigator_affiliation>
      <investigator_full_name>John Huston</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06029114
  org study id: 23-004125
  secondary id: R01AG076636
  nct id: NCT06029114
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this research is to further investigate the potential of brain stiffness as a
        novel biomarker for Alzheimer's disease.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Shear Stiffness
  time frame: Baseline
  description: Brain stiffness measured by the magnetic resonance elastography (MRE) reported in Kilopascal (kPa)
  measure: Joint mechanical-diffusion
  time frame: Baseline
  description: MRE-based measurement of white matter regions of the brain
  arm group label: Healthy Control Group
  description: Subjects will have a magnetic resonance elastography (MRE) performed.
  arm group label: Alzheimer's Disease Group
  description: Subjects will have a magnetic resonance elastography (MRE) performed.
  arm group label: Mild Cognitive Impairment Group
  description: Subjects will have a magnetic resonance elastography (MRE) performed.
  intervention type: Diagnostic Test
  intervention name: Magnetic Resonance Elastography (MRE)
  description: Imaging technique performed on a Compact 3T MRI scanner that measures the stiffness (mechanical properties) of tissues.
  arm group label: Alzheimer's Disease Group
  arm group label: Healthy Control Group
  arm group label: Mild Cognitive Impairment Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: John Huston, MD
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Timothy Waters
  phone: 507-293-0692
  email: Waters.Timothy@mayo.edu
  facility: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Principal Investigator
  investigator affiliation: Mayo Clinic
  investigator full name: John Huston
  investigator title: Principal Investigator
  mesh term: Alzheimer Disease
  mesh term: Cognitive Dysfunction
  sharing ipd: No