Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

Recruiting now

Conditions studied: Huntington's Disease

In brief

Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

Key facts

Study ID

NCT01574053

Run by

CHDI Foundation, Inc.

People needed

35000

Starts

2012-07-01

Expected to finish

2062-01-01

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Carriers: This group comprises the primary study population and consists of individuals who carry the HD gene expansion mutation.
• Controls: This group comprises the comparator study population and consists of individuals who do not carry the HD expansion mutation.
• These two major categories can be further subdivided into six different subgroups of eligible individuals:
• Manifest/Motor-manifest HD: Carriers with clinical features that are regarded in the opinion of the investigator as diagnostic of HD.
• Pre-Manifest/-Motor-manifest HD: Carriers without clinical features regarded as diagnostic of HD.
• Genotype Unknown: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has not undergone predictive testing for HD and therefore has an undetermined carrier status.
• Genotype Negative: This group includes a first or second degree relative (i.e., related by blood to a carrier) who has undergone predictive testing for HD and is known not to carry the HD expansion mutation.
• Family Control: Family members or individuals not related by blood to carriers (e.g., spouses, partners, caregivers).
• Community Controls: Individuals unrelated to HD carriers who did not grow up in a family affected by HD. Data collected from community controls will be used for generation of normative data for sub-studies.
• Participant status will be captured in the study database using 2 variables: 1) Investigator Determined Status: this will be based on clinical signs and symptoms and genotyping performed as part of medical care, and will be updated at every visit; and 2) Research Genotyping Status: this will be based on genotyping conducted as part of Enroll-HD study procedures. Based on research genotyping, participants will be reclassified under this variable from Genotype Unknown to 'Carriers' or 'Controls'. Investigators and participants will be blinded to this reclassification.

You may not qualify if…

• Individuals who do not meet inclusion criteria,
• Individuals with choreic movement disorders in the context of a negative test for the HD gene mutation.
• For Community Controls: those individuals with a major central nervous system disorder will be excluded (e.g. stroke, Parkinson's disease, multiple sclerosis, etc.).
• Participants under 18 may be eligible to participate (if they have juvenile-onset HD).

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• University of California - Irvine Medical Center — Irvine, California, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• University of California - Davis — Sacramento, California, United States (enrolling)
• University of California - San Diego — San Diego, California, United States (enrolling)
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (enrolling)
• University of Alabama — Birmingham, Alabama, United States (enrolling)
• University of California - Los Angeles — Los Angeles, California, United States (enrolling)
• Georgetown University — Washington D.C., District of Columbia, United States (enrolling)
• University of Florida Board of Trustees — Gainesville, Florida, United States (enrolling)
• University of Miami — Miami, Florida, United States (enrolling)
• University of South Florida, HDSA Center of Excellence at USF — Tampa, Florida, United States (enrolling)
• Emory University, Wesley Woods Health Center — Atlanta, Georgia, United States (enrolling)
• University of California - San Francisco — San Francisco, California, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Cenexel Rocky Mountain Clinical Research, LLC — Englewood, Colorado, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• University of Connecticut — Farmington, Connecticut, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Hereditary Neurological Disease Center — Wichita, Kansas, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• Hennepin County Medical Center — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.