Actively Recruiting

Early Phase 1
Age: 40Years - 80Years
All Genders
Healthy Volunteers
NCT06032026

Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15

Led by University of Pennsylvania · Updated on 2025-11-19

70

Participants Needed

1

Research Sites

262 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C HY-2-15. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Multiple System Atrophy (MSA). The investigators will compare uptake in people with MSA with people with Parkinson disease (PD) and progressive supranuclear palsy (PSP) as well as healthy volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (not a clinical site), Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites.

CONDITIONS

Official Title

Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15

Who Can Participate

Age: 40Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 40 to 80 years
  • Men and women clinically diagnosed with Multiple System Atrophy, Parkinson disease, progressive supranuclear palsy, or healthy controls
  • Willing and able to provide written informed consent or have a study partner to provide consent and accompany them
  • Diagnosis confirmed by consensus committee for PD, MSA, PSP, or healthy control
  • Participants asked to agree to brain donation (optional)
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Diagnosed with forms of parkinsonism other than PD, PSP, or MSA
  • History of major psychiatric disorders such as schizophrenia or bipolar disorder (major depressive disorder allowed)
  • History of significant or ongoing alcohol or substance abuse
  • Unable to tolerate imaging, arterial line, IV placement, or blood draw procedures
  • Contraindications to MRI such as incompatible implanted medical devices
  • PSP and MSA participants with prior positive beta-amyloid PET scan or positive CSF Alzheimer's disease biomarkers
  • Any medical condition or illness that may compromise safety or study participation as judged by a physician or investigator

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 Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

E

Erin o Schubert

CONTACT

M

Mary Hansbury

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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