RecruitingEarly Phase 1NCT06303921

Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503

Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-M503


Sponsor

University of Pennsylvania

Enrollment

70 participants

Start Date

Feb 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). Investigators will compare uptake in participants with PD versus participants with multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), as well as non-Parkinsonism 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) (non-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: 85 Years

Plain Language Summary

Simplified for easier understanding

This study uses a radioactive imaging agent called 11C-M503 and PET brain scans to examine how a specific brain protein is distributed and processed in people with Parkinson's disease (PD), multiple system atrophy (MSA), or progressive supranuclear palsy (PSP) — three neurodegenerative conditions that share some overlapping features. The goal is to better understand how this protein behaves in these diseases and potentially develop better diagnostic tools. **You may be eligible if...** - You are between 40 and 85 years old - You have a confirmed or suspected diagnosis of Parkinson's disease, MSA, or PSP - You are willing to provide written consent (or have a designated study partner who can assist) - You are willing to consider (though not required) brain donation after death **You may NOT be eligible if...** - You have a pacemaker or other devices incompatible with PET/MRI scanning - You have other serious medical conditions that make study procedures unsafe - You do not meet the diagnosis-specific criteria for PD, MSA, or PSP as determined by the study committee 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-M503 PET

2 hour Positron Emission Tomography (PET) scan using new radiotracer 11C-M503

DIAGNOSTIC_TESTBrain MRI

MRI scan of brain.

DIAGNOSTIC_TESTAmyloid PET

PET scan with Florbetaben F18 or 11C-PiB

BEHAVIORALNeurological assessments

Neurological assessments, including a video interview.


Locations(3)

Yale New Haven Hospital

New Haven, Connecticut, United States

Washington University in St. Louis

St Louis, Missouri, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT06303921


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