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/NCT05997030</url>
    </required_header>
    <id_info>
      <org_study_id>RNI_NMD_AD01</org_study_id>
      <nct_id>NCT05997030</nct_id>
    </id_info>
    <brief_title>Low-Intensity Focused Ultrasound (LIFU) Neuromodulation</brief_title>
    <official_title>Early Feasibility Study of Low-Intensity Focused Ultrasound (LIFU) Neuromodulation in Patients With Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ali Rezai</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>West Virginia University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a prospective, single-center, single-arm early feasibility study, to establish&#xD;
        safety and tolerability of LIFU for neuromodulation in patients with mild cognitive&#xD;
        impairment ( MCI) due to Alzheimer's disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an&#xD;
        adjunct neuromodulatory treatment for MCI due to AD&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Occurrence of Treatment Emergent Adverse Events</measure>
      <time_frame>baseline and 7 and days after study procedure</time_frame>
      <description>Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cognitive Change</measure>
      <time_frame>baseline and 7 days after procedure</time_frame>
      <description>Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Imaging Changes</measure>
      <time_frame>baseline, 7 and 30 days</time_frame>
      <description>Changes in brain metabolism and connectivity using PET and fMRI</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Alzheimer Disease</condition>
    <arm_group>
      <arm_group_label>Neuromodulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>low intensity focused ultrasound (LIFU)</intervention_name>
      <description>Subjects will undergo undergo a single LIFU of the target brain region</description>
      <arm_group_label>Neuromodulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males and non-pregnant females, aged 45-85 years&#xD;
  &#xD;
            -  Able and willing to give informed consent&#xD;
  &#xD;
            -  Must meet the clinical criteria for MCI due to Alzheimer's disease&#xD;
  &#xD;
            -  If receiving concurrent treatment with an AChEI and/or memantine, has been on a stable&#xD;
               dose for at least 45 days&#xD;
  &#xD;
            -  Able to communicate sensations during the LIFU procedure&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to undergo MR-imaging because of implanted pacemakers, medication pumps,&#xD;
               aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or&#xD;
               cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in&#xD;
               the eye that welders and other metal workers may have, or if candidates are&#xD;
               uncomfortable in small spaces (have claustrophobia).&#xD;
  &#xD;
            -  Participants with more than 30% of the skull area traversed by the sonication pathway&#xD;
               are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or&#xD;
               implanted objects in the skull or the brain.&#xD;
  &#xD;
            -  Participants with a history of seizure disorder.&#xD;
  &#xD;
            -  Participants with clinically significant chronic pulmonary disorders e.g., severe&#xD;
               emphysema, pulmonary vasculitis, or other causes of reduced pulmonary vascular&#xD;
               cross-sectional area.&#xD;
  &#xD;
            -  Participant does not speak English&#xD;
  &#xD;
            -  Participant is pregnant or planning to be pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ali Rezai</last_name>
      <role>Principal Investigator</role>
      <affiliation>WVU Rockefeller Neuroscience Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marc Haut, PhD</last_name>
      <phone>3042934816</phone>
      <email>mhaut@hsc.wvu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kiley Everson</last_name>
      <phone>3042931316</phone>
      <email>kiley.everson@hsc.wvu.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>West Virginia University</investigator_affiliation>
      <investigator_full_name>Ali Rezai</investigator_full_name>
      <investigator_title>Director RNI</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
    </condition_browse>
    <!-- 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/NCT05997030
  org study id: RNI_NMD_AD01
  nct id: NCT05997030
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  This study is a prospective, single-center, single-arm early feasibility study, to establish
        safety and tolerability of LIFU for neuromodulation in patients with mild cognitive
        impairment ( MCI) due to Alzheimer's disease.
  The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an
        adjunct neuromodulatory treatment for MCI due to AD
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Occurrence of Treatment Emergent Adverse Events
  time frame: baseline and 7 and days after study procedure
  description: Safety will be assessed by recording all adverse events that are treatment related. Each Adverse Event will be documented for patterns of occurence.
  measure: Cognitive Change
  time frame: baseline and 7 days after procedure
  description: Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
  measure: Imaging Changes
  time frame: baseline, 7 and 30 days
  description: Changes in brain metabolism and connectivity using PET and fMRI
  arm group label: Neuromodulation
  arm group type: Experimental
  description: Subjects meeting eligibility criteria will undergo Exablate low intensity focused ultrasound neuromodulation
  intervention type: Device
  intervention name: low intensity focused ultrasound (LIFU)
  description: Subjects will undergo undergo a single LIFU of the target brain region
  arm group label: Neuromodulation
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Ali Rezai
  role: Principal Investigator
  affiliation: WVU Rockefeller Neuroscience Institute
  last name: Marc Haut, PhD
  phone: 3042934816
  email: mhaut@hsc.wvu.edu
  last name: Kiley Everson
  phone: 3042931316
  email: kiley.everson@hsc.wvu.edu
  responsible party type: Sponsor-Investigator
  investigator affiliation: West Virginia University
  investigator full name: Ali Rezai
  investigator title: Director RNI
  mesh term: Alzheimer Disease