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History of Changes for Study: NCT03034122
Is Caffeine an Environmental Modifier in Huntington's Disease? (CrEAM-HD)
Latest version (submitted August 24, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 24, 2017 None (earliest Version on record)
2 December 21, 2017 Recruitment Status, Study Status and Contacts/Locations
3 February 12, 2019 Study Status
4 August 24, 2020 Study Status and Contacts/Locations
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Study NCT03034122
Submitted Date:  January 24, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2015_67
Brief Title: Is Caffeine an Environmental Modifier in Huntington's Disease? (CrEAM-HD)
Official Title: Is Caffeine an Environmental Modifier in Huntington's Disease?
Secondary IDs: 2016-A00892-49 [ID-RCB number, ANSM]
Open or close this module Study Status
Record Verification: January 2017
Overall Status: Not yet recruiting
Study Start: January 2017
Primary Completion: December 2018 [Anticipated]
Study Completion: December 2018 [Anticipated]
First Submitted: January 24, 2017
First Submitted that
Met QC Criteria:
January 24, 2017
First Posted: January 27, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 24, 2017
Last Update Posted: January 27, 2017 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital, Lille
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Huntington Disease
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 100 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Study Population: premanifest HD subjects
Sampling Method: Non-Probability Sample
Minimum Age: 21 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Clémence Simonin, MD
Email: clemence.simonin@chru-lille.fr
Study Officials: Clémence Simonin, MD
Principal Investigator
University Hospital, Lille
Locations: France
Hôpital Roger Salengro, CHRU
Lille, France
Contact:Principal Investigator: Clémence Simonin, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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