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NCT Number: NCT06082713

Extracellular Vesicles for HD

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.

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Key information

Conditions

Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. To develop more accurate biomarkers of HD progression or conversion

    Time frame: 8 years

  2. to develop standard practices for extracellular vesicle biomarker discovery research

    Time frame: 8 years

Study contacts

Contact information is provided by the study sponsor or research team.

Amoy Fraser, PhD, CCRP, PMP

CONTACT

[email protected]

4072668742

Erica Martin, B.S.

CONTACT

[email protected]

4072668742

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • University of South Florida

Registry information

Official study title

Extracellular Vesicles As Non-Invasive Biomarkers for Huntington Disease Progression and Huntingtin Lowering Therapy

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Oct 13, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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