RecruitingEarly Phase 1NCT06032026

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

Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15

Sponsor

University of Pennsylvania

Enrollment

70 participants

Start Date

Jul 20, 2023

Study Type

INTERVENTIONAL

Conditions

Tauopathies

Summary

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.

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is using a new PET imaging agent (11C-HY-2-15) to look at how it moves through the body and whether it can detect certain abnormal proteins in the brain. It is designed for people with Parkinson's disease, multiple system atrophy (MSA), progressive supranuclear palsy (PSP), or healthy volunteers. **You may be eligible if...** - You are between 40 and 80 years old - You have a clinical diagnosis of Parkinson's disease, MSA, PSP, or are a healthy volunteer - You are willing to participate in brain and/or body scanning sessions - You are able to provide informed consent (or have a study partner present) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a major psychiatric disorder such as schizophrenia or bipolar disorder - You have a history of significant alcohol or substance abuse - You have a contraindication to MRI (e.g., a metal implant) - You have had a prior positive amyloid brain scan (PSP and MSA participants only) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG11C-HY-2-15 PET

2 hour Positron Emission Tomography (PET) scan using new radiotracer 11C-HY-2-15

DIAGNOSTIC_TESTbrain MRI

brain MRI scan

DIAGNOSTIC_TESTAmyloid PET scan

PET scan with Florbetaben F18 or 11C-PiB

BEHAVIORALNeurological assessments

Neurological assessments, including video interview

Locations(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT06032026

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