Extracellular Vesicles for HD

Part of paid clinical trials in Orlando, Florida.

Sponsor
University of Central Florida
Study ID
NCT06082713
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Oct 25, 2023
Status verified
Dec 2024
Primary completion
Nov 30, 2031
Completion
Nov 30, 2031

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Huntington Disease Carriers
  • Arm: Non-Huntington Disease Carriers

Primary Outcome Measure

To discover blood-based biomarker of brain HTT protein using extracellular vesicles to be used in evaluating target engagement in HTT lowering clinical trials. [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Central FloridaOrlandoFlorida32816
Amoy Fraser, PhD, CCRP, PMP
4072668742
Erica Martin, BS
4072668742
Amber Southwell, PhD

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