NCT06082713Recruiting
Extracellular Vesicles for HD
Extracellular Vesicles As Non-Invasive Biomarkers for Huntington Disease Progression and Huntingtin Lowering Therapy
Source: ClinicalTrials.gov · Last updated 6 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 8 Oct 2023
- Start date
- 25 Oct 2023
- Primary completion date
- Nov 2031
- Lead sponsor
- University of Central Florida
- Diseases
- Huntington's disease
- NCT number
- NCT06082713
What you commit to
- Study type: Observational
- Planned participants: 100
- From 25 Oct 2023 to the primary completion date, Nov 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- receiving nutrition through a tube
- participated in a clinical drug trial within 30 days
- have needle phobia, frequent headache, significant lower spinal deformity or major surgery
- 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)
Other illness
- 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)
- positive for HIV, hepatitis B or C
- have a confirmed or suspected immunodeficient condition/state
- 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
- have a blood clotting or bruising disorder
Age
- younger than 18 or older than 75 years old
Other
- known to carry an intermediate CAG repeat between 27 and 39 or a larger expansion of 60 or more CAG repeats
- pregnant
- do not comply with or are unwilling to undertake any of the study procedures
Who the study is looking for
- 18 - 75 years of age
- can provide informed consent
- able to read and speak English
- agree to comply with study procedures (including overnight fasting, blood collection and lumbar puncture); and
- has been diagnosed with HD (HD Carriers) or not been diagnosed with HD (Non-HD Carriers).
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Central Florida Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.