Status:
RECRUITING
Extracellular Vesicles for HD
Lead Sponsor:
University of Central Florida
Collaborating Sponsors:
University of South Florida
Conditions:
Huntington Disease
Eligibility:
All Genders
18-75 years
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 clini...
Eligibility Criteria
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
- 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
- receiving nutrition through a tube
- pregnant
- participated in a clinical drug trial within 30 days
- 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 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)
- have a blood clotting or bruising disorder
- do not comply with or are unwilling to undertake any of the study procedures
Key Trial Info
Start Date :
October 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2031
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06082713
Start Date
October 25 2023
End Date
November 1 2031
Last Update
December 6 2024
Active Locations (1)
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1
University of Central Florida
Orlando, Florida, United States, 32816