<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/NCT03232697</url>
  </required_header>
  <id_info>
    <org_study_id>2016_47</org_study_id>
    <secondary_id>2017-A00131-52</secondary_id>
    <nct_id>NCT03232697</nct_id>
  </id_info>
  <brief_title>French Language Validation of the 5-minutes Montreal Cognitive Assessment (MoCA)</brief_title>
  <acronym>MoCATEL</acronym>
  <official_title>French Language Validation of the Phone Version of the Montreal Cognitive Assessment (MoCA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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 aim of the study is to validate a french version of the 5 minutes version of the Montreal&#xD;
      Cognitive Assessment as compared to the french full version of this test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Montreal Cognitive Assessment (MOCA) is a test used to detect cognitive impairments. This&#xD;
      test is available in different languages including french. A short version (the 5 minutes&#xD;
      MOCA) has also been validated through a phone call use that allows to develop some&#xD;
      epidemiological approaches. Nevertheless, this short version has not been validated in&#xD;
      french.&#xD;
&#xD;
      The main aim of the study is to validate the french translation of the short version of the&#xD;
      MOCA as compared the the full french version of the test.&#xD;
&#xD;
      To validate the short version, several groups of subjects will be included : healthy&#xD;
      subjects, Alzheimer disease patients, Parkinson or Huntington diseases patients as well as&#xD;
      diabetic patients.&#xD;
&#xD;
      The inclusion of both healthy subjects and patients with different types of cognitive&#xD;
      impairments will allow to validate the short version of the test.&#xD;
&#xD;
      All subjects and patients will first be submitted to the full version of the MOCA during a&#xD;
      face to face procedure. Thirty to forty days later, they will be submitted to the short&#xD;
      version of the test through a phone call performed by an independent rater.&#xD;
&#xD;
      Subgroups of healthy subjects and patients will also be used to determine the test-retest and&#xD;
      inter-rater reliability of the short version of the MOCA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2017</start_date>
  <completion_date type="Actual">August 8, 2019</completion_date>
  <primary_completion_date type="Actual">August 8, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Different populations including subjects with or without cognitive impairment will be used to determine the accuracy of a short version of the MOCA as compared to the full version of this scale.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between scores obtained with the different versions of the MOCA</measure>
    <time_frame>30 to 40 days</time_frame>
    <description>To measure the correlation between the results obtained at the short and full versions of the MOCA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance of the short version of the MOCA</measure>
    <time_frame>30 to 40 days</time_frame>
    <description>Receiver operator characteristic (ROC) analyses of the short version of MOCA to determine cognitive impairment as compared to full version as a gold-standard</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test-retest reliability</measure>
    <time_frame>30 to 40 days</time_frame>
    <description>To determine the test-retest reliability of the short version of the MOCA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-rater reliability</measure>
    <time_frame>30 to 40 days</time_frame>
    <description>To determine the inter-rater reliability of the short version of the MOCA</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">236</enrollment>
  <condition>Cognitive Symptom</condition>
  <condition>Evaluations, Diagnostic Self</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alzheimer patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parkinson and Huntington patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetic patients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Full version of the Montreal Cognitive Assessment</intervention_name>
    <description>Patients or subjects will be submitted to the full version of the MOCA</description>
    <arm_group_label>Alzheimer patients</arm_group_label>
    <arm_group_label>Diabetic patients</arm_group_label>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>Parkinson and Huntington patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>5 minutes version of the Montreal Cognitive Assessment</intervention_name>
    <description>The same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call</description>
    <arm_group_label>Alzheimer patients</arm_group_label>
    <arm_group_label>Diabetic patients</arm_group_label>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_label>Parkinson and Huntington patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy Volunteers&#xD;
&#xD;
          -  Volunteers, BMI &lt;26&#xD;
&#xD;
          -  free from neurological, psychiatric, metabolic or cardiac pathologies;&#xD;
&#xD;
          -  Absence of active metabolic or cardiac diseases, unstabilized under treatment&#xD;
&#xD;
          -  Pregnant test negative&#xD;
&#xD;
        Patients&#xD;
&#xD;
          -  Patients suffering from pathologies that may be accompanied by cognitive decline or&#xD;
             dementia (Alzheimer's disease, Parkinson's and Huntington's disease, diabetes) that&#xD;
             meet the usual diagnostic criteria for these diseases;&#xD;
&#xD;
          -  Patients should not start treatment of a new therapeutic class under test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing women.&#xD;
&#xD;
          -  Illiterate subjects&#xD;
&#xD;
          -  Presence of uncorrected visual or auditory disturbances&#xD;
&#xD;
          -  &quot;Alcohol use disorder&quot; observed at the Mini International Neuropsychiatric Inventory&#xD;
             (MINI);&#xD;
&#xD;
          -  &quot;Substance use disorder&quot; observed at the MINI;&#xD;
&#xD;
          -  Participation in a therapeutic trial or in an exclusion period from a previous&#xD;
             clinical trial;&#xD;
&#xD;
          -  Patient whose physical or mental condition does not allow them to pass the study&#xD;
             tests;&#xD;
&#xD;
          -  Persons under guardianship or under trusteeship;&#xD;
&#xD;
          -  Recent cognitive assessment (less than 6 months) by the classic MoCA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominique Deplanque, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2020</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>Neurobehavioral Manifestations</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03232697
org study id: 2016_47
secondary id: 2017-A00131-52
nct id: NCT03232697
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to validate a french version of the 5 minutes version of the Montreal
      Cognitive Assessment as compared to the french full version of this test.
The Montreal Cognitive Assessment (MOCA) is a test used to detect cognitive impairments. This
      test is available in different languages including french. A short version (the 5 minutes
      MOCA) has also been validated through a phone call use that allows to develop some
      epidemiological approaches. Nevertheless, this short version has not been validated in
      french.

      The main aim of the study is to validate the french translation of the short version of the
      MOCA as compared the the full french version of the test.

      To validate the short version, several groups of subjects will be included : healthy
      subjects, Alzheimer disease patients, Parkinson or Huntington diseases patients as well as
      diabetic patients.

      The inclusion of both healthy subjects and patients with different types of cognitive
      impairments will allow to validate the short version of the test.

      All subjects and patients will first be submitted to the full version of the MOCA during a
      face to face procedure. Thirty to forty days later, they will be submitted to the short
      version of the test through a phone call performed by an independent rater.

      Subgroups of healthy subjects and patients will also be used to determine the test-retest and
      inter-rater reliability of the short version of the MOCA.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Different populations including subjects with or without cognitive impairment will be used to determine the accuracy of a short version of the MOCA as compared to the full version of this scale.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Correlation between scores obtained with the different versions of the MOCA
time frame: 30 to 40 days
description: To measure the correlation between the results obtained at the short and full versions of the MOCA
measure: Performance of the short version of the MOCA
time frame: 30 to 40 days
description: Receiver operator characteristic (ROC) analyses of the short version of MOCA to determine cognitive impairment as compared to full version as a gold-standard
measure: Test-retest reliability
time frame: 30 to 40 days
description: To determine the test-retest reliability of the short version of the MOCA
measure: Inter-rater reliability
time frame: 30 to 40 days
description: To determine the inter-rater reliability of the short version of the MOCA
arm group label: Healthy subjects
arm group type: Other
description: Subjects will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment
arm group label: Alzheimer patients
arm group type: Other
description: Patients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment
arm group label: Parkinson and Huntington patients
arm group type: Other
description: Patients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment
arm group label: Diabetic patients
arm group type: Other
description: Patients will be submitted to both the full version of the Montreal Cognitive Assessment and of the 5-minutes version of the Montreal Cognitive Assessment
intervention type: Diagnostic Test
intervention name: Full version of the Montreal Cognitive Assessment
description: Patients or subjects will be submitted to the full version of the MOCA
arm group label: Alzheimer patients
arm group label: Diabetic patients
arm group label: Healthy subjects
arm group label: Parkinson and Huntington patients
intervention type: Diagnostic Test
intervention name: 5 minutes version of the Montreal Cognitive Assessment
description: The same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call
arm group label: Alzheimer patients
arm group label: Diabetic patients
arm group label: Healthy subjects
arm group label: Parkinson and Huntington patients
criteria: 
gender: All
minimum age: 40 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dominique Deplanque, MD,PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Neurobehavioral Manifestations
sharing ipd: No