Collecting cerebrospinal fluid to aid in developing treatments 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

HDClarity is an observational initiative aimed at recruiting at least 2500 participants at various stages of Huntington's disease. The study focuses on collecting high-quality cerebrospinal fluid (CSF) and plasma samples to evaluate biomarkers and pathways relevant to the disease. Participants will attend annual visits for medical history assessments and biosample collection, with the option for additional sampling in the first year. This longitudinal approach allows for comprehensive data collection to facilitate therapeutic development for Huntington's disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age (18-75 years controls, early/late premanifest HD and incomplete penetrance HD, 21-75 years early/moderate/advanced manifest HD, ≥11 years juvenile HD)
* Enroll HD participant
* Capable of consenting or have a legal representative (parent/guardian for juveniles)
* Capable of complying with study procedures
* All participants other than family and community controls must have had a genetic test for HD

Exclusion Criteria:

* Drug trial within 30 days of any sampling visit
* Changes in medication (antidepressant, psychoactive, psychotropic or other medications or nutraceuticals used to treat HD within 30 days)
* Antiplatelet or anticoagulant therapy within 14 days
* Significant comorbidity
* Needle phobia, headache, spinal surgery / deformity
* Clotting or bruising disorder
* Screening blood test abnormalities \>10% outside normal range
* Drug / alcohol abuse
* Positive urine pregnancy test at any screening or sampling visit for females of childbearing potential
* Predictable non compliance or unwillingness
* Serious adverse event related to HDClarity study procedures or any lumbar puncture procedure performed for any reason in the previous 30 days

Where it's running

• Cenexel
  Englewood, Colorado, United States Recruiting
• Georgetown University
  Washington D.C., District of Columbia, United States Recruiting
• John Hopkins University
  Baltimore, Maryland, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting
• University of Texas Health Science Center
  Houston, Texas, United States Recruiting
• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Edward J Wild, MA, MB BChir, MRCP, PhD — University College, London
• Study coordinator: Katarzyna Schubert, PhD
• Email: hdclarity-cc@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.

  Recruiting at 5 sites Phase 1 Sarepta Therapeutics, Inc. · Westmead, New South Wales and 4 other locations · NCT07536061

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

  This project will test a new PET tracer ([11C]CHDI-00491009) to see if it binds mutant huntingtin aggregates in adults with Huntington disease and in healthy volunteers.

  Recruiting Early Phase 1 CHDI Foundation, Inc. · Leuven · NCT06634628

• 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

• Global registry for Huntington's Disease

  This study is gathering health information from people with Huntington's disease and their families to help researchers learn more about the disease and find better treatments.

  Recruiting at 160 sites CHDI Foundation, Inc. · Birmingham, Alabama and 182 other locations · NCT01574053

• Pridopidine for Huntington's Disease: a 1-year, randomized, placebo-controlled study

  This trial tests whether pridopidine can slow the progression of Huntington's disease in adults compared with placebo over one year.

  Recruiting at 17 sites Phase 3 Prilenia · Birmingham, Alabama and 65 other locations · NCT07609108

• Low-intensity focused ultrasound targeting the globus pallidus to improve movement in Huntington's disease

  This trial tests whether different pulse frequencies of low-intensity focused ultrasound (LIFU) aimed at a deep brain target can safely reduce chorea and other motor symptoms in adults with Huntington's disease.

  Recruiting First Affiliated Hospital of Fujian Medical University · Fuzhou, Fujian · NCT07513844

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.