<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/NCT03034122</url>
  </required_header>
  <id_info>
    <org_study_id>2015_67</org_study_id>
    <secondary_id>2016-A00892-49</secondary_id>
    <nct_id>NCT03034122</nct_id>
  </id_info>
  <brief_title>Is Caffeine an Environmental Modifier in Huntington's Disease?</brief_title>
  <acronym>CrEAM-HD</acronym>
  <official_title>Is Caffeine an Environmental Modifier in Huntington's Disease?</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to establish if caffeine consumption is associated with the evolution&#xD;
      of the disease in premanifest HD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 11, 2017</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>Change in striatal volume</measure>
    <time_frame>at 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unified Huntington's Disease Rating Scale (UHDRS)</measure>
    <time_frame>at 1 years, at 2 years</time_frame>
    <description>measure the change of motor scale for exposure caffeine groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SDMT -symbol digit modality test</measure>
    <time_frame>at 1 years, at 2 years</time_frame>
    <description>measure the change of cognitive score for exposure caffeine groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop test</measure>
    <time_frame>at 1 years, at 2 years</time_frame>
    <description>measure the change of cognitive score for exposure caffeine groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PBA (problem behaviors assessment)</measure>
    <time_frame>at 1 years, at 2 years</time_frame>
    <description>the PBA is a semi structured clinical interview measuring the presence, severity and frequency of 11 key behavioural symptoms.&#xD;
measure the change score and subscores for apathy, obsessive-compulsive disorders, irritability, anxiety and depression,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>score at Epworth sleepiness scale</measure>
    <time_frame>at 1 years, at 2 years</time_frame>
    <description>measure the change of sleepiness scale for exposure caffeine groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI</measure>
    <time_frame>at 1 years, at 2 years</time_frame>
    <description>measure the change of image of the whole brain and other deep gray nuclei atrophy</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Huntington Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        premanifest HD subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HD mutation carriers (&gt;36 CAG)&#xD;
&#xD;
          -  premanifest (total motor UHDRS &lt; 5)&#xD;
&#xD;
          -  estimated time to diagnosis between 3 and 10 years&#xD;
&#xD;
          -  adults older than 21 years (in order to exclude juvenile patients who begin the&#xD;
             disease before 21 years)&#xD;
&#xD;
          -  informed consent signed&#xD;
&#xD;
          -  with a social protection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MRI contraindication&#xD;
&#xD;
          -  pregnant and lactating women&#xD;
&#xD;
          -  People under guardianship, trusteeship, deprive of freedom&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clémence Simonin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Clémence Simonin, MD</last_name>
    <phone>0320445962</phone>
    <phone_ext>+33</phone_ext>
    <email>clemence.simonin@chru-lille.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Amiens</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Roger Salengro, CHRU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Clémence Simonin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Nancy</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AH-HP La Pitié-Salpétrière</name>
      <address>
        <city>Paris 14</city>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AH-HP, Hôpital Henri Mondor</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Purpan</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 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>Huntington Disease</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/NCT03034122
org study id: 2015_67
secondary id: 2016-A00892-49
nct id: NCT03034122
lead sponsor: 
has dmc: Yes
The aim of the study is to establish if caffeine consumption is associated with the evolution
      of the disease in premanifest HD.
observational model: Cohort
time perspective: Prospective
measure: Change in striatal volume
time frame: at 2 years
measure: Unified Huntington's Disease Rating Scale (UHDRS)
time frame: at 1 years, at 2 years
description: measure the change of motor scale for exposure caffeine groups
measure: SDMT -symbol digit modality test
time frame: at 1 years, at 2 years
description: measure the change of cognitive score for exposure caffeine groups
measure: Stroop test
time frame: at 1 years, at 2 years
description: measure the change of cognitive score for exposure caffeine groups
measure: PBA (problem behaviors assessment)
time frame: at 1 years, at 2 years
description: the PBA is a semi structured clinical interview measuring the presence, severity and frequency of 11 key behavioural symptoms.
measure the change score and subscores for apathy, obsessive-compulsive disorders, irritability, anxiety and depression,
measure: score at Epworth sleepiness scale
time frame: at 1 years, at 2 years
description: measure the change of sleepiness scale for exposure caffeine groups
measure: MRI
time frame: at 1 years, at 2 years
description: measure the change of image of the whole brain and other deep gray nuclei atrophy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Clémence Simonin, MD
role: Principal Investigator
affiliation: University Hospital, Lille
last name: Clémence Simonin, MD
phone: 0320445962
phone ext: +33
email: clemence.simonin@chru-lille.fr
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Huntington Disease
sharing ipd: No