Blood Vesicle Markers for Huntington Disease Brain Protein Changes
Studies blood vesicles as markers of brain huntingtin protein in adults with Huntington disease.
Plain-language title generated from the registry record
Registry title: Extracellular Vesicles for HD
Key facts
- Where
- Orlando, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06082713, who can take part
Where in United States
- University of Central FloridaOrlando, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Central Florida
- Trial code
- NCT06082713
- Record updated
- 6 December 2024
- Original description
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.Read full original descriptionShow less
Extracellular Vesicles As Non-Invasive Biomarkers for Huntington Disease Progression and Huntingtin Lowering Therapy
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.
Inclusion: 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).
Exclusion: 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); 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; younger than 18 or older than 75 years old; 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.