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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
University of Pennsylvania
Study ID
NCT06303921
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Tauopathies

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • 11C-M503 PET — DRUG
    2 hour Positron Emission Tomography (PET) scan using new radiotracer 11C-M503
  • Brain MRI — DIAGNOSTIC_TEST
    MRI scan of brain.
  • Amyloid PET — DIAGNOSTIC_TEST
    PET scan with Florbetaben F18 or 11C-PiB
  • Neurological assessments — BEHAVIORAL
    Neurological assessments, including a video interview.

Study Details

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.

Key Dates

Start date
Feb 16, 2024
Status verified
Apr 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 11C-M503 PET
    Participants will undergo 11C-M503 PET scan, they may also have a brain MRI and Amyloid PET scan as well as neurological assessments.

Primary Outcome Measure

Organ Biodistribution or Dosimetry [ Time Frame: 4 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Yale New Haven HospitalNew HavenConnecticut06510
Richard Carson
[email protected]
203-932-5711
Shannan Henry
[email protected]
203-737-5278
Richard Carson (PRINCIPAL_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63110
Joel S Perlmutter, MD
[email protected]
314-362-6026
Joel S Perlmutter, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Erin Schubert
[email protected]
215-662-3041
Ilya Nasrallah, MD, PhD
[email protected]
IIya Nasrallah, MD, PhD (PRINCIPAL_INVESTIGATOR)

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