Is Caffeine an Environmental Modifier in Huntington's Disease?

Huntington Disease Clinical Trial

— CrEAM-HD  

Official title:

Is Caffeine an Environmental Modifier in Huntington's Disease?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03034122
• Other study ID #: 2015_67
• Secondary ID: 2016-A00892-49
• Status: Recruiting
• Start date: October 11, 2017
• Est. completion date: October 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: Clémence Simonin, MD
• Phone: 0320445962
• Email: clemence.simonin[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Huntington Disease

Locations

Country	Name	City	State
France	CHU de Amiens	Amiens
France	CHU de Angers	Angers
France	CHU Pellegrin	Bordeaux
France	CHU de Grenoble	Grenoble
France	Hôpital Roger Salengro, CHRU	Lille
France	CHU Montpellier	Montpellier
France	CHU de Nancy	Nancy
France	AH-HP, Hôpital Henri Mondor	Paris
France	AH-HP La Pitié-Salpétrière	Paris 14
France	CHU Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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