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

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: Completed
• Conditions: Huntington Disease

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU de Amiens
  • Angers, France
    • CHU de Angers
  • Bordeaux, France
    • CHU Pellegrin
  • Grenoble, France
    • CHU de Grenoble
  • Lille, France
    • Hôpital Roger Salengro, CHRU
  • Montpellier, France
    • CHU Montpellier
  • Nancy, France
    • CHU de Nancy
  • Paris, France, 75679
    • AH-HP La Pitié-Salpétrière
  • Paris, France
    • AH-HP, Hôpital Henri Mondor
  • Toulouse, France
    • CHU Purpan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

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	at 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Huntington's Disease Rating Scale (UHDRS)	measure the change of motor scale for exposure caffeine groups	at 1 years, at 2 years
SDMT -symbol digit modality test	measure the change of cognitive score for exposure caffeine groups	at 1 years, at 2 years
Stroop test	measure the change of cognitive score for exposure caffeine groups	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,	at 1 years, at 2 years
score at Epworth sleepiness scale	measure the change of sleepiness scale for exposure caffeine groups	at 1 years, at 2 years
MRI	measure the change of image of the whole brain and other deep gray nuclei atrophy	at 1 years, at 2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): April 12, 2024
• Study Completion (Actual): April 12, 2024

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: January 24, 2017
• First Posted (Estimated): January 27, 2017

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Neurocognitive Disorders; Cognition Disorders; Dementia; Neurodegenerative Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Basal Ganglia Diseases; Dyskinesias; Chorea; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Huntington Disease
• 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