| NCT ID | NCT06082713 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Central Florida |
| Condition | Huntington Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-25 |
| Primary Completion | 2031-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 100 participants in total. It began in 2023-10-25 with a primary completion date of 2031-11.
⚠ 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
The primary objective of this study is to discover blood-based biomarker of brain Huntingtin (HTT) protein using extracellular vesicles to be used in evaluating target engagement in HTT lowering clinical trials. Secondary objectives of this study include developing more accurate biomarkers of Huntington disease (HD) progression or conversion and to develop standard practices for extracellular vesicle biomarker discovery research. The investigators hypothesize that brain-derived extracellular vesicles (EVs) isolated from human biofluids contain biological cargo specific to their tissue of origin that could allow their use as brain biomarkers for HD. EVs are lipid bilayer-delimited particles that are naturally released from cells in the brain. The investigators will investigate if EVs contents reflect the pathological alterations occurring with disease progression when compared with EVs isolated from biofluids of healthy non-HD persons.
Eligibility Criteria
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
Contact & Investigator
Amber Southwell, PhD
PRINCIPAL INVESTIGATOR
University of Central Florida Burnett School of Biomedical Sciences
Frequently Asked Questions
Who can join the NCT06082713 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Huntington Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06082713 currently recruiting?
Yes, NCT06082713 is actively recruiting participants. Contact the research team at amoy.fraser@ucf.edu for enrollment information.
Where is the NCT06082713 trial being conducted?
This trial is being conducted at Orlando, United States.
Who is sponsoring the NCT06082713 clinical trial?
NCT06082713 is sponsored by University of Central Florida. The principal investigator is Amber Southwell, PhD at University of Central Florida Burnett School of Biomedical Sciences. The trial plans to enroll 100 participants.