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/NCT06011681</url>
    </required_header>
    <id_info>
      <org_study_id>MH202206MCILLD</org_study_id>
      <nct_id>NCT06011681</nct_id>
    </id_info>
    <brief_title>The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over</brief_title>
    <official_title>The Proactive Screening and Diagnosis of Mild Cognitive Impairment and Depression in Patients Ages 60 and Over: An Implementation Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Miro Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Miro Health</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Mild cognitive impairment (MCI) leading to Alzheimer's disease and related disorders (ADRD)&#xD;
        represents a significant health and economic burden of the rapidly expanding senior&#xD;
        population. The accurate detection and diagnosis of MCI and its common comorbidity, late-life&#xD;
        depression (LLD), is essential for prolonging patient quality of life and developing&#xD;
        advancements in research and treatment options. The purpose of the proposed program is to&#xD;
        refine Miro Health's A.I. to accurately detect, differentiate and diagnose MCI and LLD.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 9, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</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>Measure usability of Miro Health assessments (iOS and Android) for patients</measure>
      <time_frame>Year 1, Q3 - Year 2, Q2</time_frame>
      <description>Measure the (a) time point 1 in-assessment drop-out rate; and (b) the rate of lost-to-time-point-2-followup at 12 months.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Measure acceptability of Miro Health assessments (iOS and Android) for patients</measure>
      <time_frame>Year 1, Q3 - Year 2, Q2</time_frame>
      <description>Measure the participant preference for pencil-paper test or Miro Health Mobile Assessment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment</measure>
      <time_frame>Year 1, Q1 - Year 2, Q2</time_frame>
      <description>Pairwise correlations greater than 0.8 and statistically significantly greater than 0.7 will be considered successful.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Measure relevance of algorithms in separating depressed, MCI, and healthy control groups</measure>
      <time_frame>Year 1, Q1 - Year 2, Q2</time_frame>
      <description>Measure AUROC for: MCI vs healthy control; MCI vs aMCI; MCI vs depression; aMCI vs healthy control; aMCI vs depression; depression vs healthy control; and MCI + depression vs healthy control. AUROC equal to or greater than 0.84 is considered successful.</description>
    </other_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">960</enrollment>
    <condition>Depression</condition>
    <condition>Mild Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>Depression</arm_group_label>
      <description>Seniors diagnosed with late life depression or with a concern of late life depression.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mild cognitive impairment</arm_group_label>
      <description>Seniors with self-reported decline in cognitive function or with a diagnosis of mild cognitive impairment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy controls</arm_group_label>
      <description>Seniors with no neurological or psychiatric symptoms or conditions.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will include healthy, worried well, depressed, and mild cognitively&#xD;
          impaired seniors from multiple, disparate U.S. geographic regions.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  LLD: Age 60 or over; diagnosis of LLD or symptoms consonant with LLD; PHQ-9 score from&#xD;
               15 to 27&#xD;
  &#xD;
            -  MCI: Age 60 or over; diagnosis of MCI or self-reported insidious onset and continued&#xD;
               worsening of cognitive decline; intact activities of daily living&#xD;
  &#xD;
            -  HC: Age 60 or over&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age 59 or younger; history of unresolved neurological or psychiatric conditions;&#xD;
               current medications known to affect cognition; history of substance abuse; unable to&#xD;
               perform activities of daily living; change in employment status due to condition&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shenly Glenn, BS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Miro Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shenly Glenn</last_name>
      <phone>4 1 5- 3 1 7 -3 9 3 9</phone>
      <email>shenly@mirohealth.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>J o e l M e f f o r d, PHD</last_name>
      <phone>5 1 0 - 2 9 2 - 8 0 1 7</phone>
      <email>j o e l @ m i r o h e a l t h . c o m</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2022</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Cognitive Dysfunction</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/NCT06011681
  org study id: MH202206MCILLD
  nct id: NCT06011681
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Mild cognitive impairment (MCI) leading to Alzheimer's disease and related disorders (ADRD)
        represents a significant health and economic burden of the rapidly expanding senior
        population. The accurate detection and diagnosis of MCI and its common comorbidity, late-life
        depression (LLD), is essential for prolonging patient quality of life and developing
        advancements in research and treatment options. The purpose of the proposed program is to
        refine Miro Health's A.I. to accurately detect, differentiate and diagnose MCI and LLD.
  observational model: Cohort
  time perspective: Prospective
  measure: Measure usability of Miro Health assessments (iOS and Android) for patients
  time frame: Year 1, Q3 - Year 2, Q2
  description: Measure the (a) time point 1 in-assessment drop-out rate; and (b) the rate of lost-to-time-point-2-followup at 12 months.
  measure: Measure acceptability of Miro Health assessments (iOS and Android) for patients
  time frame: Year 1, Q3 - Year 2, Q2
  description: Measure the participant preference for pencil-paper test or Miro Health Mobile Assessment
  measure: Measure domain score correlations of pencil-paper tests and Miro Health Mobile Assessment
  time frame: Year 1, Q1 - Year 2, Q2
  description: Pairwise correlations greater than 0.8 and statistically significantly greater than 0.7 will be considered successful.
  measure: Measure relevance of algorithms in separating depressed, MCI, and healthy control groups
  time frame: Year 1, Q1 - Year 2, Q2
  description: Measure AUROC for: MCI vs healthy control; MCI vs aMCI; MCI vs depression; aMCI vs healthy control; aMCI vs depression; depression vs healthy control; and MCI + depression vs healthy control. AUROC equal to or greater than 0.84 is considered successful.
  arm group label: Depression
  description: Seniors diagnosed with late life depression or with a concern of late life depression.
  arm group label: Mild cognitive impairment
  description: Seniors with self-reported decline in cognitive function or with a diagnosis of mild cognitive impairment.
  arm group label: Healthy controls
  description: Seniors with no neurological or psychiatric symptoms or conditions.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shenly Glenn, BS
  role: Principal Investigator
  affiliation: Miro Health
  last name: Shenly Glenn
  phone: 4 1 5- 3 1 7 -3 9 3 9
  email: shenly@mirohealth.com
  last name: J o e l M e f f o r d, PHD
  phone: 5 1 0 - 2 9 2 - 8 0 1 7
  email: j o e l @ m i r o h e a l t h . c o m
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Cognitive Dysfunction