NCT01574053 Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort
| NCT ID | NCT01574053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHDI Foundation, Inc. |
| Condition | Huntington's Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 35,000 participants |
| Start Date | 2012-07 |
| Primary Completion | 2062-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35,000 participants in total. It began in 2012-07 with a primary completion date of 2062-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Contact & Investigator
Noopur Modi
✉ Info@Enroll-HD.orgBernhard G Landwehrmeyer, MD, PhD
PRINCIPAL INVESTIGATOR
University of Ulm
Frequently Asked Questions
Who can join the NCT01574053 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Huntington's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01574053 currently recruiting?
Yes, NCT01574053 is actively recruiting participants. Contact the research team at Info@Enroll-HD.org for enrollment information.
Where is the NCT01574053 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Irvine, United States, Loma Linda, United States and 11 additional locations.
Who is sponsoring the NCT01574053 clinical trial?
NCT01574053 is sponsored by CHDI Foundation, Inc.. The principal investigator is Bernhard G Landwehrmeyer, MD, PhD at University of Ulm. The trial plans to enroll 35,000 participants.