Is Caffeine an Environmental Modifier in Huntington's Disease?

Recruiting

• Conditions: Huntington Disease

• Registration Number: NCT03034122
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-24
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-27
• Study Start: 2017-10-11
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in striatal volume	at 2 years

Secondary Outcome Measures

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

Trial Locations

Locations (10)

CHU de Amiens; 🇫🇷 Amiens, France

CHU de Angers; 🇫🇷 Angers, France

CHU Pellegrin; 🇫🇷 Bordeaux, France

Hôpital Roger Salengro, CHRU; 🇫🇷 Lille, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de Nancy; 🇫🇷 Nancy, France

AH-HP La Pitié-Salpétrière; 🇫🇷 Paris 14, France

AH-HP, Hôpital Henri Mondor; 🇫🇷 Paris, France

CHU Purpan; 🇫🇷 Toulouse, France