Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-10-25
2031-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Huntington Disease Carriers
No interventions assigned to this group
Non-Huntington Disease Carriers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
Yes
Sponsors
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University of South Florida
OTHER
University of Central Florida
OTHER
Responsible Party
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Principal Investigators
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Amber Southwell, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Central Florida Burnett School of Biomedical Sciences
Locations
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University of Central Florida
Orlando, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Amoy Fraser, PhD, CCRP, PMP
Role: primary
Erica Martin, BS
Role: backup
Amber Southwell, PhD
Role: backup
Other Identifiers
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STUDY00004597
Identifier Type: -
Identifier Source: org_study_id