Huntington DiseaseCrEAM-HDNCT03034122
Is Caffeine an Environmental Modifier in Huntington's Disease?
An observational study of Huntington Disease, run by University Hospital, Lille at 10 sites in France.
Trial summary
The aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest HD. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Huntington Disease
- How many people
- 77 participants
- Where
- 10 sitesFrance
- Study dates
- 11 Oct 2017to 12 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: premanifest HD subjects
Who may be able to join
- 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
Who cannot join
- MRI contraindication
- pregnant and lactating women
- People under guardianship, trusteeship, deprive of freedom
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU de Amiens
Amiens
CHU de Angers
Angers
CHU Pellegrin
Bordeaux
CHU de Grenoble
Grenoble
Hôpital Roger Salengro, CHRU
Lille
CHU Montpellier
Montpellier
CHU de Nancy
Nancy
AH-HP La Pitié-Salpétrière
Paris, 75679
AH-HP, Hôpital Henri Mondor
Paris
CHU Purpan
Toulouse
About this study
The aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest HD.
- Conditions
- Huntington Disease
- Medical subject headings
- Huntington Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in striatal volume
Measured: at 2 years
Secondary outcomes (6)
Unified Huntington's Disease Rating Scale (UHDRS)
measure the change of motor scale for exposure caffeine groups
Measured: at 1 years, at 2 years
SDMT -symbol digit modality test
measure the change of cognitive score for exposure caffeine groups
Measured: at 1 years, at 2 years
Stroop test
measure the change of cognitive score for exposure caffeine groups
Measured: at 1 years, at 2 years
PBA (problem behaviors assessment)
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,
Measured: at 1 years, at 2 years
score at Epworth sleepiness scale
measure the change of sleepiness scale for exposure caffeine groups
Measured: at 1 years, at 2 years
MRI
measure the change of image of the whole brain and other deep gray nuclei atrophy
Measured: at 1 years, at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start11 Oct 2017
- Primary completion12 Apr 2024
- Study completion12 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clémence Simonin, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034122
- Sponsor's protocol ID
- 2015_67
- Other IDs
- 2016-A00892-49
- Acronym
- CrEAM-HD
- Status last verified
- Dec 2024
- First submitted
- 24 Jan 2017
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Caffeine an Environmental Modifier in Huntington's Disease?
- ClinicalTrials.gov ID
- NCT03034122
- Acronym / sponsor ID
- CrEAM-HD / 2015_67
- Conditions
- Huntington Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 12 Apr 2024 (actual)
- Study completion
- 12 Apr 2024 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest HD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- premanifest HD subjects
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- MRI contraindication
- pregnant and lactating women
- People under guardianship, trusteeship, deprive of freedom
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in striatal volume
Time frame: at 2 years
6 secondary outcomes
Unified Huntington's Disease Rating Scale (UHDRS)
Time frame: at 1 years, at 2 years
SDMT -symbol digit modality test
Time frame: at 1 years, at 2 years
Stroop test
Time frame: at 1 years, at 2 years
PBA (problem behaviors assessment)
Time frame: at 1 years, at 2 years
score at Epworth sleepiness scale
Time frame: at 1 years, at 2 years
MRI
Time frame: at 1 years, at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clémence Simonin, MD principal investigator
University Hospital, Lille
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by University Hospital, Lille at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in striatal volume (time frame: at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.