Using blood samples to find biomarkers for Huntington 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

This observational study aims to identify blood-based biomarkers of the Huntingtin protein associated with Huntington Disease (HD) by analyzing extracellular vesicles. The researchers will compare the contents of these vesicles from individuals with HD to those from healthy individuals to assess their potential as indicators of disease progression. The study also seeks to establish standard practices for biomarker discovery using extracellular vesicles, which are naturally released particles from brain cells. By understanding the biological cargo of these vesicles, the study hopes to enhance the evaluation of therapies targeting HTT lowering in future clinical trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 - 75 years of age
2. can provide informed consent
3. able to read and speak English
4. agree to comply with study procedures (including overnight fasting, blood collection and lumbar puncture); and
5. has been diagnosed with HD (HD Carriers) or not been diagnosed with HD (Non-HD Carriers).

Exclusion Criteria:

1. younger than 18 or older than 75 years old
2. known to carry an intermediate CAG repeat between 27 and 39 or a larger expansion of 60 or more CAG repeats
3. receiving nutrition through a tube
4. pregnant
5. participated in a clinical drug trial within 30 days
6. use prescribed or non-prescribed medications that are not compatible with collection of the study samples (those that may cause excessive bleeding or prevent clotting)
7. positive for HIV, hepatitis B or C
8. have a confirmed or suspected immunodeficient condition/state
9. significant medical, psychiatric, or neurological morbidity is observed by the clinic physician on the day of sample collection that might impair completion of the study procedures
10. have needle phobia, frequent headache, significant lower spinal deformity or major surgery
11. received antiplatelet or anticoagulant therapy within 14 days prior to sample collection (including but not limited to: aspirin, clopidogrel, dipyridamole, warfarin, dabigatran, rivaroxaban and apixaban)
12. have a blood clotting or bruising disorder
13. do not comply with or are unwilling to undertake any of the study procedures

Where it's running

• University of Central Florida
  Orlando, Florida, United States Recruiting

Study contacts

• Principal investigator: Amber Southwell, PhD — University of Central Florida Burnett School of Biomedical Sciences
• Study coordinator: Amoy Fraser, PhD, CCRP, PMP
• Email: amoy.fraser@ucf.edu
• Phone: 4072668742

Similar studies

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

• 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

• Safety and tolerability of human neural stem cell implants for Huntington's disease

  This research will test whether an implant of hNSC-01 human neural stem cells is safe and tolerable for adults with Huntington's disease.

  Recruiting Phase 1/2 University of California, Irvine · Irvine, California · NCT07451613

• SKY-0515 for adults with Huntington's disease

  This trial will test whether the oral drug SKY-0515 can lower harmful huntingtin protein and improve symptoms in adults aged 25 and older with genetically confirmed Huntington's disease.

  Recruiting at 19 sites Phase 2/3 Skyhawk Therapeutics, Inc. · Englewood, Colorado and 30 other locations · NCT07378644

• Votoplam for adults with early symptomatic Huntington's disease

  This trial will test whether votoplam (HTT227) is safe and can slow disease progression in adults with early symptomatic Huntington's disease.

  Recruiting at 117 sites Phase 3 Novartis · Birmingham, Alabama and 116 other locations · NCT07326709

• Comparing three social cognition tests in adults with early Huntington disease

  This project will test whether the DMASC-MC and two established social cognition tests can detect social thinking problems in adults with early Huntington disease.

  Recruiting Region Skane · Lund · NCT07253038

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.