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

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ClinicalTrials.gov Identifier: NCT03034122
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date January 24, 2017
First Posted Date January 27, 2017
Last Update Posted Date February 15, 2019
Actual Study Start Date October 11, 2017
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 24, 2017)
Change in striatal volume [ Time Frame: at 2 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03034122 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 24, 2017)
  • Unified Huntington's Disease Rating Scale (UHDRS) [ Time Frame: at 1 years, at 2 years ]
    measure the change of motor scale for exposure caffeine groups
  • SDMT -symbol digit modality test [ Time Frame: at 1 years, at 2 years ]
    measure the change of cognitive score for exposure caffeine groups
  • Stroop test [ Time Frame: at 1 years, at 2 years ]
    measure the change of cognitive score for exposure caffeine groups
  • PBA (problem behaviors assessment) [ Time Frame: 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,
  • score at Epworth sleepiness scale [ Time Frame: at 1 years, at 2 years ]
    measure the change of sleepiness scale for exposure caffeine groups
  • MRI [ Time Frame: at 1 years, at 2 years ]
    measure the change of image of the whole brain and other deep gray nuclei atrophy
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Is Caffeine an Environmental Modifier in Huntington's Disease?
Official Title Is Caffeine an Environmental Modifier in Huntington's Disease?
Brief Summary The aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest HD.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population premanifest HD subjects
Condition Huntington Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 24, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Clémence Simonin, MD 0320445962 ext +33 clemence.simonin@chru-lille.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03034122
Other Study ID Numbers 2015_67
2016-A00892-49 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Clémence Simonin, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date February 2019