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CrEAM-HD: Is Caffeine an Environmental Modifier in Huntington's Disease?

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT03034122
Collaborator
(none)
100
Enrollment
10
Locations
64.6
Anticipated Duration (Months)
10
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest HD.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Is Caffeine an Environmental Modifier in Huntington's Disease?
    Actual Study Start Date :
    Oct 11, 2017
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Change in striatal volume [at 2 years]

    Secondary Outcome Measures

    1. Unified Huntington's Disease Rating Scale (UHDRS) [at 1 years, at 2 years]

      measure the change of motor scale for exposure caffeine groups

    2. SDMT -symbol digit modality test [at 1 years, at 2 years]

      measure the change of cognitive score for exposure caffeine groups

    3. Stroop test [at 1 years, at 2 years]

      measure the change of cognitive score for exposure caffeine groups

    4. PBA (problem behaviors assessment) [at 1 years, at 2 years]

      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,

    5. score at Epworth sleepiness scale [at 1 years, at 2 years]

      measure the change of sleepiness scale for exposure caffeine groups

    6. MRI [at 1 years, at 2 years]

      measure the change of image of the whole brain and other deep gray nuclei atrophy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • HD mutation carriers (>36 CAG)

    • premanifest (total motor UHDRS < 5)

    • estimated time to diagnosis between 3 and 10 years

    • adults older than 21 years (in order to exclude juvenile patients who begin the disease before 21 years)

    • informed consent signed

    • with a social protection

    Exclusion Criteria:

    • MRI contraindication

    • pregnant and lactating women

    • People under guardianship, trusteeship, deprive of freedom

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU de Amiens Amiens France
    2 CHU de Angers Angers France
    3 CHU Pellegrin Bordeaux France
    4 CHU de Grenoble Grenoble France
    5 Hôpital Roger Salengro, CHRU Lille France
    6 CHU Montpellier Montpellier France
    7 CHU de Nancy Nancy France
    8 AH-HP La Pitié-Salpétrière Paris 14 France 75679
    9 AH-HP, Hôpital Henri Mondor Paris France
    10 CHU Purpan Toulouse France

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Clémence Simonin, MD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT03034122
    Other Study ID Numbers:
    • 2015_67
    • 2016-A00892-49
    First Posted:
    Jan 27, 2017
    Last Update Posted:
    Aug 25, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Huntington Disease

    Study Results

    No Results Posted as of Aug 25, 2020