Global registry for Huntington's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Enroll-HD is a longitudinal, observational study that combines two existing Huntington's disease registries and expands to include participants from Latin America. It aims to create a comprehensive repository of clinical data and biological specimens from individuals with Huntington's disease, their relatives, and control participants. The study involves over 30,000 participants and includes annual assessments to gather rich longitudinal data that can be used for research on disease progression and biomarkers. The data collected is made available to researchers to facilitate further studies in the field.

Why it matters

Who can join: the full rules

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).

Where it's running

• University of Alabama
  Birmingham, Alabama, United States Recruiting
• St. Joseph's Hospital and Medical Center
  Phoenix, Arizona, United States Recruiting
• University of California - Irvine Medical Center
  Irvine, California, United States Recruiting
• University of California - Los Angeles
  Los Angeles, California, United States Recruiting
• University of California - Davis
  Sacramento, California, United States Recruiting
• University of California - San Diego
  San Diego, California, United States Recruiting

+133 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Bernhard G Landwehrmeyer, MD, PhD — University of Ulm
• Study coordinator: Noopur Modi
• Email: Info@Enroll-HD.org

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• First-in-human test of SRP-1005 in Huntington's disease

  This first-in-human study tests SRP-1005 versus placebo in people with Huntington's disease to see if it is safe and tolerable.

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• New PET tracer ([11C]CHDI-00491009) to image mutant huntingtin in Huntington disease

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• Evaluating ALN-HTT02 for treating Huntington's disease in adults

  This study is testing a new drug called ALN-HTT02 to see if it is safe and effective for adults with early-stage Huntington's disease.

  Recruiting at 19 sites Phase 1 Alnylam Pharmaceuticals · Edmonton and 18 other locations · NCT06585449

• Collecting cerebrospinal fluid to aid in developing treatments for Huntington's disease

  This study is collecting spinal fluid and blood samples from people with Huntington's disease to help find better treatments for the condition.

  Recruiting at 32 sites University College, London · Englewood, Colorado and 39 other locations · NCT02855476

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.