Actively Recruiting

Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06082713

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

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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

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University of Central Florida

Orlando, Florida, United States, 32816

Actively Recruiting

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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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