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

NCT06303921 EARLY_PHASE1 RECRUITING

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.

Details

Lead sponsor	University of Pennsylvania
Phase	EARLY_PHASE1
Status	RECRUITING
Enrolment	70
Start date	2024-02-16
Completion	2029-02

Conditions

• Tauopathies

Interventions

• 11C-M503 PET
• Brain MRI
• Amyloid PET
• Neurological assessments

Primary outcomes

• Organ Biodistribution or Dosimetry — 4 weeks
  Determine biodistribution of the radioactive investigational drug, 11C-M503 and calculate human dosimetry. A second IV or an arterial line may be placed in the arm contralateral to the side of injection for blood metabolite analysis and/or radioactive counts at various times during the scanning session. Biodistribution, metabolism, excretion and pilot brain uptake data will be collected and human dosimetry will be calculated.
• PET Uptake of Tracer — 4 weeks
  Determine whether there is selective uptake of 11C-M503 in people with MSA compared to healthy volunteers, PD and PSP participants.

Countries

United States