Is Caffeine an Environmental Modifier in Huntington's Disease?

N/ACompletedNCT03034122

University Hospital, Lille77 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

77

Conditions

Huntington Disease

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (10)

CHU de Amiens

Amiens, France

CHU de Angers

Angers, France

CHU Pellegrin

Bordeaux, France

CHU de Grenoble

Grenoble, France

Outcomes

Primary Outcomes

Change in striatal volume

Time frame: at 2 years

Secondary Outcomes

Unified Huntington's Disease Rating Scale (UHDRS)

measure the change of motor scale for exposure caffeine groups

Time frame: at 1 years, at 2 years

SDMT -symbol digit modality test

measure the change of cognitive score for exposure caffeine groups

Time frame: at 1 years, at 2 years

Stroop test

measure the change of cognitive score for exposure caffeine groups

Time frame: 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,

Time frame: at 1 years, at 2 years

score at Epworth sleepiness scale

measure the change of sleepiness scale for exposure caffeine groups

Time frame: at 1 years, at 2 years

MRI

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

Time frame: at 1 years, at 2 years

Data from ClinicalTrials.gov

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