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/NCT05983575</url>
    </required_header>
    <id_info>
      <org_study_id>LB1101</org_study_id>
      <nct_id>NCT05983575</nct_id>
    </id_info>
    <brief_title>A Pivotal Study of LIPUS-Brain in Patients With Early Alzheimer's Disease</brief_title>
    <official_title>A Study to Evaluate the Efficacy and Safety of LIPUS-Brain Transcranial Low-intensity Pulsed-wave Ultrasound Device in Patients With Early Alzheimer's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sound Wave Innovation CO., LTD.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sound Wave Innovation CO., LTD.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a multicenter, randomized, double-blinded, placebo-controlled Phase 3 study&#xD;
        comparing LIPUS-Brain transcranial low-intensity pulsed-wave ultrasound device to placebo in&#xD;
        patients with Early Alzheimer's Disease. The primary objective of the study is to assess&#xD;
        changes in ADAS-J-cog-14 scores from baseline to 72 weeks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2026</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in ADAS-J-cog-14 scores from baseline to Week 72</measure>
      <time_frame>Performed at Week 72</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in ADAS-J-cog-14 scores from baseline to Week 24 and 48</measure>
      <time_frame>Performed at Week 24 and 48</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in CDR-SB from baseline to Week 48 and 72</measure>
      <time_frame>Performed at Week 48 and 72</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in NPIQ-J scores from baseline to Week 24, 48 and 72</measure>
      <time_frame>Performed at Week 24, 48 and 72</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in J-ZBI scores from baseline to Week 24, 48 and 72</measure>
      <time_frame>Performed at Week 24, 48 and 72</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in WMS-R scores from baseline to Week 24, 48 and 72</measure>
      <time_frame>Performed at Week 24, 48 and 72</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in MMSE-J scores from baseline to Week 24, 48 and 72</measure>
      <time_frame>Performed at Week 24, 48 and 72</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in FAQ scores from baseline to Week 24, 48 and 72</measure>
      <time_frame>Performed at Week 24, 48 and 72</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in EQ-5D-5L scores from baseline to Week 24, 48 and 72</measure>
      <time_frame>Performed at Week 24, 48 and 72</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in ABC Dementia scale scores from baseline to Week 24, 48 and 72</measure>
      <time_frame>Performed at Week 24, 48 and 72</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in each 14 item of ADAS-J-cog-14 score from baseline to Week 24, 48 and 72</measure>
      <time_frame>Performed at Week 24, 48 and 72</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevalence of responders at Week 24, 48, and 72 defined as those with no deterioration or even improvement in ADAS-J-cog-14 scores</measure>
      <time_frame>Performed at Week 24, 48 and 72</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Transition rate from MCI due to AD to AD at Week 72</measure>
      <time_frame>Performed at Week 72</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Termination due to aggravation of dementia symptoms</measure>
      <time_frame>Performed up to 96 weeks</time_frame>
      <description>If medication needs to be started or changed, dementia is considered worsening.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">220</enrollment>
    <condition>Alzheimer Disease, Early Onset</condition>
    <arm_group>
      <arm_group_label>LIPUS-Brain</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>LIPUS-Brain</intervention_name>
      <description>Transcranial low-power pulsed-wave ultrasound device</description>
      <arm_group_label>LIPUS-Brain</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provide written informed consent to participate in the clinical trial from the patient&#xD;
               and their legal representative.&#xD;
  &#xD;
            -  Mild AD or MCI due to AD patient aged greater than or equal to (&gt;=) 50 and less than&#xD;
               (&lt;) 90 years, at the time of informed consent.&#xD;
  &#xD;
            -  Patients with the same partner/informant who meet all of the following conditions&#xD;
               during the study period&#xD;
  &#xD;
                 -  Living with or in contact with the patient&#xD;
  &#xD;
                 -  It is possible to observe the patient's activities of daily living and physical&#xD;
                    condition.&#xD;
  &#xD;
                 -  Being able to be present at all times during the efficacy evaluation specified in&#xD;
                    this clinical trial&#xD;
  &#xD;
                 -  Person judged by an investigator to be able to manage administration of&#xD;
                    concomitant medications&#xD;
  &#xD;
            -  Patients who met the diagnostic criteria of Mild AD or MCI due to AD according to the&#xD;
               NIA/AA 2018 diagnostic criteria at the time of informed consent and were diagnosed as&#xD;
               positive by the amyloid PET imaging evaluation committee.&#xD;
  &#xD;
            -  Have a CDR global score of 0.5 (MCI due to AD) to 1.0 (Mild AD) at screening.&#xD;
  &#xD;
            -  Patients with her MMSE-J score &gt;=20 at screening.&#xD;
  &#xD;
            -  No organic diseases such as symptomatic cerebral hemorrhage, symptomatic cerebral&#xD;
               infarction, acute cerebral infarction, brain tumor, etc. within 48 weeks before&#xD;
               obtaining informed consent or in head MRI images at screening, and in head MRA images,&#xD;
               Patients evaluated by the imaging evaluation committee as not having severe&#xD;
               stenosis/occlusion from the internal carotid artery to the middle cerebral artery.&#xD;
  &#xD;
            -  Patients who are receiving existing drug therapy for Mild AD or MCI due to AD and are&#xD;
               not scheduled to change their medication within the past 4 weeks from obtaining&#xD;
               consent and after obtaining consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients judged by the investigator that it is difficult to continue the study&#xD;
               treatment for 20 minutes.&#xD;
  &#xD;
            -  Patients judged by the investigator to be difficult to perform an MRI examination.&#xD;
  &#xD;
            -  Patients with impaired consciousness with a GCS score of 12 or less at the time of&#xD;
               enrollment.&#xD;
  &#xD;
            -  Patients who have had symptomatic cerebral infarction or cerebral hemorrhage within 12&#xD;
               weeks prior to enrollment.&#xD;
  &#xD;
            -  Patients with a modified Hachinski Ischemic Scale score of 5 or more at enrollment.&#xD;
  &#xD;
            -  Patients with Lewy body dementia and frontotemporal dementia.&#xD;
  &#xD;
            -  Patients judged by the investigator to be difficult to participate in the clinical&#xD;
               trial due to severe mental illness&#xD;
  &#xD;
            -  Poorly controlled serious systemic disease (heart failure, liver failure, renal&#xD;
               failure, vitamin B12 deficiency, hypothyroidism, etc.) that makes it difficult for the&#xD;
               investigator to participate in the study judged patient.&#xD;
  &#xD;
            -  Patients with uncontrolled diabetic retinopathy (with active fundus hemorrhage).&#xD;
  &#xD;
            -  Patients who have malignant tumor as a complication or who have been treated for&#xD;
               malignant tumor within 5 years from the time of enrollment (excluding cured resected&#xD;
               carcinoma in situ).&#xD;
  &#xD;
            -  Patients who are or have a history of drug addiction or alcohol addiction.&#xD;
  &#xD;
            -  Patients with or with a history of epilepsy.&#xD;
  &#xD;
            -  Patients with implants such as coils, electrodes and stents in the skull.&#xD;
  &#xD;
            -  Patients within 5 years after brain surgery (including endovascular treatment).&#xD;
  &#xD;
            -  Patients who are pregnant or wish to become pregnant.&#xD;
  &#xD;
            -  Patients participating in other clinical studies (excluding non-interventional&#xD;
               observational studies) or clinical trials.&#xD;
  &#xD;
            -  Patients who are otherwise judged to be ineligible by the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hiroaki Shimokawa</last_name>
      <role>Study Director</role>
      <affiliation>Sound Wave Innovation CO., LTD.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sound Wave Innovation CO., LTD.</last_name>
      <phone>+81-3-6661-2457</phone>
      <email>Lipus-brain-trial@sw-innovation.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Nagoya University Hospital</name>
        <address>
          <city>Nagoya</city>
          <state>Aichi</state>
          <zip>466-8560</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Fujita Health University Hospital</name>
        <address>
          <city>Toyoake</city>
          <state>Aichi</state>
          <zip>470-1192</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>National Center for Geriatrics and Gerontology</name>
        <address>
          <city>Ōbu</city>
          <state>Aichi</state>
          <zip>474-8511</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>IUHW Narita Hospital</name>
        <address>
          <city>Narita</city>
          <state>Chiba</state>
          <zip>286-8520</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sapporo Medical University Hospital</name>
        <address>
          <city>Sapporo</city>
          <state>Hokkaido</state>
          <zip>060-8543</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memory Clinic Toride</name>
        <address>
          <city>Toride</city>
          <state>Ibaragi</state>
          <zip>302-0004</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Kanazawa University Hospital</name>
        <address>
          <city>Kanazawa</city>
          <state>Ishikawa</state>
          <zip>920-8641</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>National Cerebral and Cardiovascular Center</name>
        <address>
          <city>Suita</city>
          <state>Osaka</state>
          <zip>564-8565</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Memory Clinic Ochanomizu</name>
        <address>
          <city>Bunkyō-Ku</city>
          <state>Tokyo</state>
          <zip>113-0034</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The University of Tokyo Hospital</name>
        <address>
          <city>Bunkyō-Ku</city>
          <state>Tokyo</state>
          <zip>113-8655</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tokyo Metropolitan Geriatrics Hospital</name>
        <address>
          <city>Itabashi-ku</city>
          <state>Tokyo</state>
          <zip>173-0015</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tottori University Hospital</name>
        <address>
          <city>Yonago</city>
          <state>Tottori</state>
          <zip>683-8504</zip>
          <country>Japan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sound Wave Innovation CO., LTD.</last_name>
        <phone>+81-3-6661-2457</phone>
        <email>Lipus-brain-trial@sw-innovation.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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/NCT05983575
  org study id: LB1101
  nct id: NCT05983575
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a multicenter, randomized, double-blinded, placebo-controlled Phase 3 study
        comparing LIPUS-Brain transcranial low-intensity pulsed-wave ultrasound device to placebo in
        patients with Early Alzheimer's Disease. The primary objective of the study is to assess
        changes in ADAS-J-cog-14 scores from baseline to 72 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Changes in ADAS-J-cog-14 scores from baseline to Week 72
  time frame: Performed at Week 72
  measure: Changes in ADAS-J-cog-14 scores from baseline to Week 24 and 48
  time frame: Performed at Week 24 and 48
  measure: Changes in CDR-SB from baseline to Week 48 and 72
  time frame: Performed at Week 48 and 72
  measure: Changes in NPIQ-J scores from baseline to Week 24, 48 and 72
  time frame: Performed at Week 24, 48 and 72
  measure: Changes in J-ZBI scores from baseline to Week 24, 48 and 72
  time frame: Performed at Week 24, 48 and 72
  measure: Changes in WMS-R scores from baseline to Week 24, 48 and 72
  time frame: Performed at Week 24, 48 and 72
  measure: Changes in MMSE-J scores from baseline to Week 24, 48 and 72
  time frame: Performed at Week 24, 48 and 72
  measure: Changes in FAQ scores from baseline to Week 24, 48 and 72
  time frame: Performed at Week 24, 48 and 72
  measure: Changes in EQ-5D-5L scores from baseline to Week 24, 48 and 72
  time frame: Performed at Week 24, 48 and 72
  measure: Changes in ABC Dementia scale scores from baseline to Week 24, 48 and 72
  time frame: Performed at Week 24, 48 and 72
  measure: Changes in each 14 item of ADAS-J-cog-14 score from baseline to Week 24, 48 and 72
  time frame: Performed at Week 24, 48 and 72
  measure: Prevalence of responders at Week 24, 48, and 72 defined as those with no deterioration or even improvement in ADAS-J-cog-14 scores
  time frame: Performed at Week 24, 48 and 72
  measure: Transition rate from MCI due to AD to AD at Week 72
  time frame: Performed at Week 72
  measure: Termination due to aggravation of dementia symptoms
  time frame: Performed up to 96 weeks
  description: If medication needs to be started or changed, dementia is considered worsening.
  arm group label: LIPUS-Brain
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Device
  intervention name: LIPUS-Brain
  description: Transcranial low-power pulsed-wave ultrasound device
  arm group label: LIPUS-Brain
  intervention type: Device
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 89 Years
  healthy volunteers: No
  last name: Hiroaki Shimokawa
  role: Study Director
  affiliation: Sound Wave Innovation CO., LTD.
  last name: Sound Wave Innovation CO., LTD.
  phone: +81-3-6661-2457
  email: Lipus-brain-trial@sw-innovation.com
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: Japan
  responsible party type: Sponsor
  mesh term: Alzheimer Disease