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

NCT06303921 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • Tauopathies

Interventions

DRUG

11C-M503 PET

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

DIAGNOSTIC_TEST

Brain MRI

MRI scan of brain.

DIAGNOSTIC_TEST

Amyloid PET

PET scan with Florbetaben F18 or 11C-PiB

BEHAVIORAL

Neurological assessments

Neurological assessments, including a video interview.

Sponsors & Collaborators

Principal Investigators

  • Ilya M Nasrallah, MD, PhD · University of Pennsylvania

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-16
Primary Completion
2029-02-28
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06303921 on ClinicalTrials.gov