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/NCT06032611</url>
    </required_header>
    <id_info>
      <org_study_id>COGNUM</org_study_id>
      <secondary_id>IDRCB2022-A00609-34</secondary_id>
      <nct_id>NCT06032611</nct_id>
    </id_info>
    <brief_title>Interest of Two Digital Devices for the Diagnosis of Neurocognitive Disorders in Elderly People With Cognitive Symptoms.</brief_title>
    <official_title>Interest of Two Digital Devices for the Diagnosis of Neurocognitive Disorders in Elderly People With Cognitive Symptoms.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RIVAGES</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Université d'Évry</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hôpital Charles Foix</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>RIVAGES</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 goal of this clinical trial is to compare conventional clinical data collected as part of&#xD;
        usual practice with data collected by the two digital tools to help diagnose major and minor&#xD;
        neurocognitive disorders in elderly people consulting a memory center for cognitive&#xD;
        complaints. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Is it possible to create a classification between the different intensities of cognitive&#xD;
             impairment?&#xD;
  &#xD;
          -  Is it possible to create a diagnostic tool consistent with the reference diagnosis?&#xD;
             Participants will be asked to complete a series of cognitive and fine motor tasks, and&#xD;
             will be given questionnaires on their lifestyle and medical history. They will be asked&#xD;
             to wear a connected watch for 1 week.&#xD;
  &#xD;
        There is no comparison group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Alzheimer's disease, which leads to dementia, has an insidious onset and a slow, gradual&#xD;
        progression. After a completely asymptomatic phase that can last several years (prodromal&#xD;
        stage of the disease), the first signs consist of a moderate deterioration in performance in&#xD;
        one or more cognitive domains, such as memory, attention, planning or other cognitive&#xD;
        faculties. Clinically, this is referred to as mild neurocognitive impairment (MCI) due to&#xD;
        Alzheimer's disease. The progression is towards a major neurocognitive disorder, in which&#xD;
        cognitive dysfunction progressively increases, and the patient becomes dependent for&#xD;
        activities of daily living. Early detection of the disease, and specifically of this mild&#xD;
        neurocognitive disorder, is crucial for a window of intervention prior to dementia. The&#xD;
        investigators propose to evaluate a tablet version of a manual dexterity test that the&#xD;
        investigators have already been able to test, in combination with assessments already&#xD;
        established in the clinic and physiological data collected by a connected watch, to help&#xD;
        diagnose neurocognitive disorders by confronting them with the clinical data that are the&#xD;
        reference.&#xD;
  &#xD;
        The investigators propose this multicenter observational study with a diagnostic aim. The&#xD;
        study will involve 150 elderly people consulting one of the two participating memory centers.&#xD;
        Three groups will be formed: 50 people with no cognitive dysfunction, 50 with a mild&#xD;
        neurocognitive disorder, and 50 with a major neurocognitive disorder linked to Alzheimer's&#xD;
        disease. These groups will be formed on the basis of the reference diagnosis established by&#xD;
        the memory consultation teams, and the results of the patient's neuropsychological and&#xD;
        medical assessments. The investigators will retrieve data from the medical record to classify&#xD;
        cognitive status.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 17, 2023</start_date>
    <completion_date type="Anticipated">April 17, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 17, 2024</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Sensitivity, specificity, accuracy</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Sensitivity, specificity, accuracy of the classification proposed by the algorithm in relation to the reference diagnosis.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Age-related Cognitive Decline</condition>
    <condition>Computers, Handheld</condition>
    <condition>Neurocognitive Disorders</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will complete a number of cognitive and fine motor tests on a touch-sensitive tablet. They will also be asked to complete a questionnaire on their habits and medical history. They will also be asked to wear a smartwatch for 7 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>COGNUM_ALZVR</intervention_name>
      <description>Participants will complete a battery of tests/quizzes:&#xD;
  cognitive tests&#xD;
  medical questionnaire&#xD;
  lifestyle/fragility questionnaire&#xD;
  digital clock test&#xD;
  fine motor skills tests They will also wear a connected watch for 7 days.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  elderly people consulting the memory center ;&#xD;
  &#xD;
            -  people with one of three documented cognitive diagnoses:&#xD;
  &#xD;
            -  major neurocognitive impairment due to Alzheimer's disease according to DSM-5&#xD;
               criteria,&#xD;
  &#xD;
            -  mild neurocognitive impairment&#xD;
  &#xD;
            -  no documented cognitive dysfunction after assessment at the memory center,&#xD;
  &#xD;
            -  willingness to participate in the study and sign the consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  persons with an illness affecting the hand (orthopedic, neurological, Parkinson's&#xD;
               disease) that prevents them from using a touch-sensitive tablet;&#xD;
  &#xD;
            -  persons with other illnesses that may be responsible for loss of cognitive function&#xD;
               (cerebrovascular disease, other neurological illnesses, psychiatric illnesses);&#xD;
  &#xD;
            -  persons benefiting from legal protection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>110 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Joël Belmin</last_name>
      <phone>0149594565</phone>
      <email>j.belmin@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nathavy Um Din</last_name>
      <phone>0149594568</phone>
      <email>nathavy.umdin@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hôpital Privé Gériatrique Les Magnolias</name>
        <address>
          <city>Ballainvilliers</city>
          <state>Essonne</state>
          <zip>91160</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Florian Maronnat</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hôpital Charles Foix</name>
        <address>
          <city>Ivry-sur-Seine</city>
          <state>Val De Marne</state>
          <zip>94200</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Joël Belmin</last_name>
      </contact>
      <contact_backup>
        <last_name>Nathavy Um Din</last_name>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>tablet</keyword>
    <keyword>smartwatch</keyword>
    <keyword>diagnosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neurobehavioral Manifestations</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
      <mesh_term>Neurocognitive Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Personal data is password-protected and not shared; only investigators have access to this data. Study data that is shared is pseudonymized by a unique alphanumeric code generated by the application.</ipd_description>
    </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/NCT06032611
  org study id: COGNUM
  secondary id: IDRCB2022-A00609-34
  nct id: NCT06032611
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare conventional clinical data collected as part of
        usual practice with data collected by the two digital tools to help diagnose major and minor
        neurocognitive disorders in elderly people consulting a memory center for cognitive
        complaints. The main question[s] it aims to answer are:
  
          -  Is it possible to create a classification between the different intensities of cognitive
             impairment?
  
          -  Is it possible to create a diagnostic tool consistent with the reference diagnosis?
             Participants will be asked to complete a series of cognitive and fine motor tasks, and
             will be given questionnaires on their lifestyle and medical history. They will be asked
             to wear a connected watch for 1 week.
  
        There is no comparison group.
  Alzheimer's disease, which leads to dementia, has an insidious onset and a slow, gradual
        progression. After a completely asymptomatic phase that can last several years (prodromal
        stage of the disease), the first signs consist of a moderate deterioration in performance in
        one or more cognitive domains, such as memory, attention, planning or other cognitive
        faculties. Clinically, this is referred to as mild neurocognitive impairment (MCI) due to
        Alzheimer's disease. The progression is towards a major neurocognitive disorder, in which
        cognitive dysfunction progressively increases, and the patient becomes dependent for
        activities of daily living. Early detection of the disease, and specifically of this mild
        neurocognitive disorder, is crucial for a window of intervention prior to dementia. The
        investigators propose to evaluate a tablet version of a manual dexterity test that the
        investigators have already been able to test, in combination with assessments already
        established in the clinic and physiological data collected by a connected watch, to help
        diagnose neurocognitive disorders by confronting them with the clinical data that are the
        reference.
  
        The investigators propose this multicenter observational study with a diagnostic aim. The
        study will involve 150 elderly people consulting one of the two participating memory centers.
        Three groups will be formed: 50 people with no cognitive dysfunction, 50 with a mild
        neurocognitive disorder, and 50 with a major neurocognitive disorder linked to Alzheimer's
        disease. These groups will be formed on the basis of the reference diagnosis established by
        the memory consultation teams, and the results of the patient's neuropsychological and
        medical assessments. The investigators will retrieve data from the medical record to classify
        cognitive status.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Sensitivity, specificity, accuracy
  time frame: through study completion, an average of 1 year
  description: Sensitivity, specificity, accuracy of the classification proposed by the algorithm in relation to the reference diagnosis.
  arm group label: Intervention
  arm group type: Experimental
  description: Participants will complete a number of cognitive and fine motor tests on a touch-sensitive tablet. They will also be asked to complete a questionnaire on their habits and medical history. They will also be asked to wear a smartwatch for 7 days.
  intervention type: Diagnostic Test
  intervention name: COGNUM_ALZVR
  description: Participants will complete a battery of tests/quizzes:
  cognitive tests
  medical questionnaire
  lifestyle/fragility questionnaire
  digital clock test
  fine motor skills tests They will also wear a connected watch for 7 days.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 110 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Joël Belmin
  phone: 0149594565
  email: j.belmin@aphp.fr
  last name: Nathavy Um Din
  phone: 0149594568
  email: nathavy.umdin@gmail.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  mesh term: Neurobehavioral Manifestations
  mesh term: Cognitive Dysfunction
  mesh term: Neurocognitive Disorders
  sharing ipd: No
  ipd description: Personal data is password-protected and not shared; only investigators have access to this data. Study data that is shared is pseudonymized by a unique alphanumeric code generated by the application.