Is Caffeine an Environmental Modifier in Huntington's Disease?
CrEAM-HD
2 other identifiers
observational
77
1 country
10
Brief Summary
The aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest HD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2017
CompletedFirst Posted
Study publicly available on registry
January 27, 2017
CompletedStudy Start
First participant enrolled
October 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2024
CompletedDecember 23, 2025
December 1, 2024
6.5 years
January 24, 2017
December 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in striatal volume
at 2 years
Secondary Outcomes (6)
Unified Huntington's Disease Rating Scale (UHDRS)
at 1 years, at 2 years
SDMT -symbol digit modality test
at 1 years, at 2 years
Stroop test
at 1 years, at 2 years
PBA (problem behaviors assessment)
at 1 years, at 2 years
score at Epworth sleepiness scale
at 1 years, at 2 years
- +1 more secondary outcomes
Eligibility Criteria
premanifest HD subjects
You may qualify if:
- 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
You may not qualify if:
- MRI contraindication
- pregnant and lactating women
- People under guardianship, trusteeship, deprive of freedom
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
CHU de Amiens
Amiens, France
CHU de Angers
Angers, France
CHU Pellegrin
Bordeaux, France
CHU de Grenoble
Grenoble, France
Hôpital Roger Salengro, CHRU
Lille, France
CHU Montpellier
Montpellier, France
CHU de Nancy
Nancy, France
AH-HP La Pitié-Salpétrière
Paris, 75679, France
AH-HP, Hôpital Henri Mondor
Paris, France
CHU Purpan
Toulouse, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clémence Simonin, MD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2017
First Posted
January 27, 2017
Study Start
October 11, 2017
Primary Completion
April 12, 2024
Study Completion
April 12, 2024
Last Updated
December 23, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share