Actively Recruiting
Extracellular Vesicles for HD
Led by University of Central Florida · Updated on 2024-12-06
100
Participants Needed
1
Research Sites
418 weeks
Total Duration
On this page
Sponsors
U
University of Central Florida
Lead Sponsor
U
University of South Florida
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Extracellular Vesicles for HD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 75 years old
- Be able to provide informed consent
- Be able to read and speak English
- Agree to follow study procedures including overnight fasting, blood collection, and lumbar puncture
- Have been diagnosed with Huntington Disease or not diagnosed with Huntington Disease
You will not qualify if you...
- Be younger than 18 or older than 75 years old
- Carry an intermediate CAG repeat between 27 and 39 or a larger expansion of 60 or more CAG repeats
- Receiving nutrition through a tube
- Be pregnant
- Participated in a clinical drug trial within the last 30 days
- Use medications that may cause excessive bleeding or prevent clotting
- Test positive for HIV, hepatitis B or C
- Have a confirmed or suspected immunodeficient condition
- Have significant medical, psychiatric, or neurological conditions affecting study completion
- Have needle phobia, frequent headaches, significant lower spinal deformity, or major surgery
- Received antiplatelet or anticoagulant therapy within 14 days before sample collection
- Have blood clotting or bruising disorders
- Are unwilling or unable to follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Central Florida
Orlando, Florida, United States, 32816
Actively Recruiting
Research Team
A
Amoy Fraser, PhD, CCRP, PMP
CONTACT
E
Erica Martin, B.S.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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