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Completed

NCT Number: NCT03034122

Is Caffeine an Environmental Modifier in Huntington's Disease?

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

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in striatal volume

    Time frame: at 2 years

Secondary outcomes

  1. 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

  2. SDMT -symbol digit modality test

    Time frame: at 1 years, at 2 years

    measure the change of cognitive score for exposure caffeine groups

  3. Stroop test

    Time frame: at 1 years, at 2 years

    measure the change of cognitive score for exposure caffeine groups

  4. 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,

  5. score at Epworth sleepiness scale

    Time frame: at 1 years, at 2 years

    measure the change of sleepiness scale for exposure caffeine groups

  6. MRI

    Time frame: at 1 years, at 2 years

    measure the change of image of the whole brain and other deep gray nuclei atrophy

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: CrEAM-HD

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2017
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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