<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/NCT04490330</url>
  </required_header>
  <id_info>
    <org_study_id>PI2019_843_0106</org_study_id>
    <nct_id>NCT04490330</nct_id>
  </id_info>
  <brief_title>Screening for Alcohol-related Cognitive Impairments in Cirrhotic Patients</brief_title>
  <acronym>CirCo</acronym>
  <official_title>Screening for Alcohol-related Cognitive Impairments in Cirrhotic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</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>
      80% of patients with alcohol use disorders (AUD) present cognitive impairments, such as&#xD;
      memory and executive functions. These disorders may have repercussions in addiction treatment&#xD;
      by altering the patient's adherence to care. The level of impairment is dependent on the&#xD;
      onset of addiction, and also the duration of abstinence.&#xD;
&#xD;
      A complete neuropsychological evaluation is necessary to highlight cognitive impairments. In&#xD;
      practice, the evaluation of these disorders by practitioners, is done with the help of tools&#xD;
      of screening like the MoCa (Montreal cognitive assesment) and the BEARNI (Brief evaluation of&#xD;
      alcohol related neuropsychological impairment).&#xD;
&#xD;
      However, none of these tools have been evaluated in patients with alcoholic cirrhosis.&#xD;
      Indeed, some studies have suggested that liver disorders including cirrhosis may be a factor&#xD;
      aggravating cognitive disorders.&#xD;
&#xD;
      The purpose of this study is to evaluate the ability of the BEARNI tool to detect&#xD;
      alcohol-related cognitive problems in patients with alcohol-related cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>number of alcoholic cirrhosis patients with presence of alcohol-related cognitive disorders</measure>
    <time_frame>day 1</time_frame>
    <description>the number of alcoholic cirrhosis patients with presence of alcohol-related cognitive disorders will be measured by using the BEARNI screening tool. BEARNI screening tool is Brief evaluation of alcohol related neuropsychological impairment.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Alcohol Dependence</condition>
  <condition>Dependence</condition>
  <condition>Cognitive Impairments</condition>
  <condition>Cirrhosis</condition>
  <condition>Liver Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>AUDIT questionnaire (alcohol use disorders identification test)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with alcoholic cirrhosis will be evaluated with BEARNI tool in order to detect&#xD;
        alcohol-related cognitive problems.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with cirrhosis&#xD;
&#xD;
          -  patients with cirrhosis diagnosed by clinical examination&#xD;
&#xD;
          -  patients with cirrhosis diagnosed by biological and / or morphological and / or&#xD;
             noninvasive tests and / or liver biopsy&#xD;
&#xD;
          -  CHILD A, B or C&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hepatitis encephalopathy less than 6 months old&#xD;
&#xD;
          -  complicated cirrhosis with hepatocellular carcinoma&#xD;
&#xD;
          -  Acute alcoholic hepatitis&#xD;
&#xD;
          -  viral cirrhosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Bernard ANGERVILLE, MD</last_name>
    <phone>(33)322068297</phone>
    <email>angerville.bernard@chu-amiens.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80480</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bernard ANGERVILLE, MD</last_name>
      <phone>(33)322068297</phone>
      <email>angerville.bernard@chu-amiens.fr</email>
    </contact>
    <contact_backup>
      <last_name>Eric NGUYEN -KHAC, Pr</last_name>
      <phone>(33)322088851</phone>
      <email>nguyenkhac.eric@chu-amiens.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alcohol Dependence</keyword>
  <keyword>Dependence</keyword>
  <keyword>Cognitive Impairments</keyword>
  <keyword>Cirrhosis</keyword>
  <keyword>Liver Diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
    <mesh_term>Alcoholism</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/NCT04490330
org study id: PI2019_843_0106
nct id: NCT04490330
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
80% of patients with alcohol use disorders (AUD) present cognitive impairments, such as
      memory and executive functions. These disorders may have repercussions in addiction treatment
      by altering the patient's adherence to care. The level of impairment is dependent on the
      onset of addiction, and also the duration of abstinence.

      A complete neuropsychological evaluation is necessary to highlight cognitive impairments. In
      practice, the evaluation of these disorders by practitioners, is done with the help of tools
      of screening like the MoCa (Montreal cognitive assesment) and the BEARNI (Brief evaluation of
      alcohol related neuropsychological impairment).

      However, none of these tools have been evaluated in patients with alcoholic cirrhosis.
      Indeed, some studies have suggested that liver disorders including cirrhosis may be a factor
      aggravating cognitive disorders.

      The purpose of this study is to evaluate the ability of the BEARNI tool to detect
      alcohol-related cognitive problems in patients with alcohol-related cirrhosis.
observational model: Case-Only
time perspective: Prospective
measure: number of alcoholic cirrhosis patients with presence of alcohol-related cognitive disorders
time frame: day 1
description: the number of alcoholic cirrhosis patients with presence of alcohol-related cognitive disorders will be measured by using the BEARNI screening tool. BEARNI screening tool is Brief evaluation of alcohol related neuropsychological impairment.
intervention type: Other
intervention name: questionnaire
description: AUDIT questionnaire (alcohol use disorders identification test)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bernard ANGERVILLE, MD
phone: (33)322068297
email: angerville.bernard@chu-amiens.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fibrosis
mesh term: Alcoholism
mesh term: Cognitive Dysfunction
sharing ipd: No