<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/NCT03811184</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A02672-53</org_study_id>
    <nct_id>NCT03811184</nct_id>
  </id_info>
  <brief_title>Validation of a Smartphone Application for the Assessment of Patients With Mild Cognitive Impairment: MemScreen</brief_title>
  <acronym>MemScreen</acronym>
  <official_title>Validation of a Smartphone Application for the Assessment of Patients With Mild Cognitive Impairment: MemScreen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MemScreen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MemScreen</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 clinical evaluation of a patient with a cognitive complaint requires neuropsychological&#xD;
      tests, evaluating the integrity of memory and other cognitive functions.&#xD;
&#xD;
      The initial evaluation is made most often by a doctor (general practitioner). In case of need&#xD;
      for further examination, a neuropsychological report is made in consultation memory by a&#xD;
      neuropsychologist, with further cognitive tests.&#xD;
&#xD;
      The Cognitive Neurology Center at Lariboisière Hospital - Fernand Widal has developed a tool&#xD;
      on a digital tablet or smartphone to evaluate cognitive functions: MemScreen.&#xD;
&#xD;
      The purpose of this study is to validate this new neuropsychological test on tablet compared&#xD;
      to the neuropsychological reference tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Characteristics of MemScreen :&#xD;
&#xD;
        -  Smartphone / tablet application developed by the Cognitive Neurology Center at&#xD;
           Lariboisière - Fernand Widal Hospital to explore a patient with a cognitive disorder.&#xD;
&#xD;
        -  The application is a self-test by the patient under the supervision of a doctor.&#xD;
&#xD;
        -  The doctor has an account to be able to pass the test to patients.&#xD;
&#xD;
        -  The tablet test is anonymous without the possibility to identify the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</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>Ability to detect patients with mild cognitive impairment.</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>To evaluate the ability of MemScreen to discriminate patients with an objective memory disorder from a validated neuropsychological reference test: the free and cued selective reminding test.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Cognitive Impairment</condition>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>MemScreen</arm_group_label>
    <description>Each participants will undergo MemScreen : a screening tool on smartphone for detecting mild cognitive impairment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MemScreen</intervention_name>
    <description>Neuropsychological test on smartphone or digital tablet, on self assesment.</description>
    <arm_group_label>MemScreen</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Population seen on memory clinic for memory complaints.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patients followed in memory clinic.&#xD;
&#xD;
          -  Performing a neuropsychological assessment less than 6 months old.&#xD;
&#xD;
          -  No visual or motor deficiency impeding the use of a digital tablet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julien Dumurgier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cognitive Neurology Center of Lariboisiere Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julien Dumurgier, MD</last_name>
    <phone>0033140054313</phone>
    <email>julien.dumurgier@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claire Paquet, MD</last_name>
    <phone>0033140054313</phone>
    <email>claire.paquet@inserm.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Neurologie Cognitive Hôpital Fernand Widal</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julien Dumurgier, MD</last_name>
      <phone>0033140054313</phone>
      <email>julien.dumurgier@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>August 14, 2019</last_update_submitted>
  <last_update_submitted_qc>August 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2019</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>
    <mesh_term>Cognitive Dysfunction</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/NCT03811184
org study id: 2018-A02672-53
nct id: NCT03811184
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The clinical evaluation of a patient with a cognitive complaint requires neuropsychological
      tests, evaluating the integrity of memory and other cognitive functions.

      The initial evaluation is made most often by a doctor (general practitioner). In case of need
      for further examination, a neuropsychological report is made in consultation memory by a
      neuropsychologist, with further cognitive tests.

      The Cognitive Neurology Center at Lariboisière Hospital - Fernand Widal has developed a tool
      on a digital tablet or smartphone to evaluate cognitive functions: MemScreen.

      The purpose of this study is to validate this new neuropsychological test on tablet compared
      to the neuropsychological reference tests.
Characteristics of MemScreen :

        -  Smartphone / tablet application developed by the Cognitive Neurology Center at
           Lariboisière - Fernand Widal Hospital to explore a patient with a cognitive disorder.

        -  The application is a self-test by the patient under the supervision of a doctor.

        -  The doctor has an account to be able to pass the test to patients.

        -  The tablet test is anonymous without the possibility to identify the patient.
observational model: Cohort
time perspective: Prospective
measure: Ability to detect patients with mild cognitive impairment.
time frame: through study completion, an average of 6 months
description: To evaluate the ability of MemScreen to discriminate patients with an objective memory disorder from a validated neuropsychological reference test: the free and cued selective reminding test.
arm group label: MemScreen
description: Each participants will undergo MemScreen : a screening tool on smartphone for detecting mild cognitive impairment.
intervention type: Diagnostic Test
intervention name: MemScreen
description: Neuropsychological test on smartphone or digital tablet, on self assesment.
arm group label: MemScreen
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Julien Dumurgier, MD
role: Principal Investigator
affiliation: Cognitive Neurology Center of Lariboisiere Hospital
last name: Julien Dumurgier, MD
phone: 0033140054313
email: julien.dumurgier@aphp.fr
last name: Claire Paquet, MD
phone: 0033140054313
email: claire.paquet@inserm.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Cognitive Dysfunction
sharing ipd: No