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

January 26, 2023 updated by: University Hospital, Lille
The aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest HD.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • CHU de Amiens
      • Angers, France
        • Recruiting
        • CHU de Angers
      • Bordeaux, France
        • Recruiting
        • CHU Pellegrin
      • Grenoble, France
        • Recruiting
        • Chu de Grenoble
      • Lille, France
        • Recruiting
        • Hôpital Roger Salengro, CHRU
        • Principal Investigator:
          • Clémence Simonin, MD
      • Montpellier, France
        • Recruiting
        • CHU Montpellier
      • Nancy, France
        • Recruiting
        • Chu de Nancy
      • Paris, France
        • Recruiting
        • AH-HP, Hôpital Henri Mondor
      • Paris 14, France, 75679
        • Recruiting
        • AH-HP La Pitié-Salpétrière
      • Toulouse, France
        • Recruiting
        • CHU Purpan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

premanifest HD subjects

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in striatal volume
Time Frame: at 2 years
at 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 1 years, at 2 years
SDMT -symbol digit modality test
Time Frame: at 1 years, at 2 years
measure the change of cognitive score for exposure caffeine groups
at 1 years, at 2 years
Stroop test
Time Frame: at 1 years, at 2 years
measure the change of cognitive score for exposure caffeine groups
at 1 years, at 2 years
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,
at 1 years, at 2 years
score at Epworth sleepiness scale
Time Frame: at 1 years, at 2 years
measure the change of sleepiness scale for exposure caffeine groups
at 1 years, at 2 years
MRI
Time Frame: at 1 years, at 2 years
measure the change of image of the whole brain and other deep gray nuclei atrophy
at 1 years, at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2017

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

January 24, 2017

First Submitted That Met QC Criteria

January 24, 2017

First Posted (Estimate)

January 27, 2017

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015_67
  • 2016-A00892-49 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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