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Is Caffeine an Environmental Modifier in Huntington's Disease?

Is Caffeine an Environmental Modifier in Huntington's Disease?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03034122
Acronym
CrEAM-HD
Enrollment
77
Registered
2017-01-27
Start date
2017-10-11
Completion date
2024-04-12
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington Disease

Brief summary

The aim of the study is to establish if caffeine consumption is associated with the evolution of the disease in premanifest HD.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in striatal volumeat 2 years

Secondary

MeasureTime frameDescription
SDMT -symbol digit modality testat 1 years, at 2 yearsmeasure the change of cognitive score for exposure caffeine groups
Stroop testat 1 years, at 2 yearsmeasure the change of cognitive score for exposure caffeine groups
Unified Huntington's Disease Rating Scale (UHDRS)at 1 years, at 2 yearsmeasure the change of motor scale for exposure caffeine groups
score at Epworth sleepiness scaleat 1 years, at 2 yearsmeasure the change of sleepiness scale for exposure caffeine groups
MRIat 1 years, at 2 yearsmeasure the change of image of the whole brain and other deep gray nuclei atrophy
PBA (problem behaviors assessment)at 1 years, at 2 yearsthe 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,

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026