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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 : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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
Huntington Disease

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

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Change in striatal volume [ Time Frame: at 2 years ]

Secondary Outcome Measures :
  1. 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

  2. SDMT -symbol digit modality test [ Time Frame: at 1 years, at 2 years ]
    measure the change of cognitive score for exposure caffeine groups

  3. Stroop test [ Time Frame: at 1 years, at 2 years ]
    measure the change of cognitive score for exposure caffeine groups

  4. 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,


  5. score at Epworth sleepiness scale [ Time Frame: at 1 years, at 2 years ]
    measure the change of sleepiness scale for exposure caffeine groups

  6. MRI [ Time Frame: at 1 years, at 2 years ]
    measure the change of image of the whole brain and other deep gray nuclei atrophy


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
premanifest HD subjects
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034122


Contacts
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Contact: Clémence Simonin, MD 0320445962 ext +33 clemence.simonin@chru-lille.fr

Locations
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France
CHU de Amiens Recruiting
Amiens, France
CHU de Angers Recruiting
Angers, France
CHU Pellegrin Recruiting
Bordeaux, France
CHU de Grenoble Recruiting
Grenoble, France
Hôpital Roger Salengro, CHRU Recruiting
Lille, France
Principal Investigator: Clémence Simonin, MD         
CHU Montpellier Recruiting
Montpellier, France
CHU de Nancy Recruiting
Nancy, France
AH-HP La Pitié-Salpétrière Recruiting
Paris 14, France, 75679
AH-HP, Hôpital Henri Mondor Recruiting
Paris, France
CHU Purpan Recruiting
Toulouse, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Clémence Simonin, MD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03034122    
Other Study ID Numbers: 2015_67
2016-A00892-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
 Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders