Is Caffeine an Environmental Modifier in Huntington's Disease? (CrEAM-HD)

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ClinicalTrials.gov Identifier: NCT03034122

Recruitment Status : Recruiting

First Posted : January 27, 2017

Last Update Posted : August 25, 2020

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

University Hospital, Lille

Tracking Information

First Submitted Date

January 24, 2017

First Posted Date

January 27, 2017

Last Update Posted Date

August 25, 2020

Actual Study Start Date

October 11, 2017

Estimated Primary Completion Date

March 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Change in striatal volume [ Time Frame: at 2 years ]

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

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
SDMT -symbol digit modality test [ Time Frame: at 1 years, at 2 years ]
measure the change of cognitive score for exposure caffeine groups
Stroop test [ Time Frame: at 1 years, at 2 years ]
measure the change of cognitive score for exposure caffeine groups
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,
score at Epworth sleepiness scale [ Time Frame: at 1 years, at 2 years ]
measure the change of sleepiness scale for exposure caffeine groups
MRI [ Time Frame: at 1 years, at 2 years ]
measure the change of image of the whole brain and other deep gray nuclei atrophy

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Is Caffeine an Environmental Modifier in Huntington's Disease?

Official Title

Is Caffeine an Environmental Modifier in Huntington's 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.

Detailed Description

Not Provided

Study Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

premanifest HD subjects

Condition

Huntington Disease

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Recruiting

Estimated Enrollment

100

Original Estimated Enrollment

Same as current

Estimated Study Completion Date

March 2023

Estimated Primary Completion Date

March 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

21 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact: Clémence Simonin, MD

0320445962 ext +33

clemence.simonin@chru-lille.fr

Listed Location Countries

France

Removed Location Countries

Administrative Information

NCT Number

NCT03034122

Other Study ID Numbers

2015_67
2016-A00892-49 ( Other Identifier: ID-RCB number, ANSM )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

University Hospital, Lille

Study Sponsor

University Hospital, Lille

Collaborators

Not Provided

Investigators

Principal Investigator:

Clémence Simonin, MD

University Hospital, Lille

PRS Account

University Hospital, Lille

Verification Date

August 2020

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