Recruiting
Early Phase 1

11C-M503

Sponsor:

University of Pennsylvania

Code:

NCT06303921

Conditions

Tauopathies

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

11C-M503 PET

Brain MRI

Amyloid PET

Neurological assessments

Study Details

Brief 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

Study ID

NCT06303921

Start date

Feb 16, 2024

Status verified date

Apr, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients in all cohorts will be male or female adults from 40 to 85 years of age.
  • Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures or Participants who are deemed unable to provide informed consent must have a designated study partner present for consent and to accompany them to study visits
  • Investigators will ask PD/MSA/PSP participants to agree to brain donation but this choice is not mandatory for participation in this study.
  • Diagnosis-specific inclusion criteria: Clinical diagnoses will be determined by consensus committee for diagnostic agreement (PD, MSA, PSP or Healthy Control)

Exclusion Criteria:

  • Females who are pregnant or breast feeding will be excluded, a urine pregnancy test will be performed in women of child-bearing potential prior to injection of 11C -M503, 11C-PiB or 18F-Florbetaben
  • Forms of parkinsonism other than PD, PSP and MSA as defined above
  • Major psychiatric disorder (e.g. schizophrenia or bipolar disorder) - major depressive disorder is allowed
  • History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
  • Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician
  • Contraindication to MRI, such as non-compatible implanted medical device
  • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician or investigator to be a condition that could compromise participant safety or successful participation in the study

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

11C-M503 PET

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

Brain MRI

MRI scan of brain.

Amyloid PET

PET scan with Florbetaben F18 or 11C-PiB

Neurological assessments

Neurological assessments, including a video interview.

Primary outcome measure

  • Organ Biodistribution or Dosimetry [ Time Frame: 4 weeks ]
  • PET Uptake of Tracer [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Erin Schubert

215-662-3041erinshu@pennmedicine.upenn.edu

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Richard Carson

203-932-5711richard.carson@yale.edu

Shannan Henry

203-737-5278shannan.henry@yale.edu

Principal Investigator:

Richard Carson

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Joel S Perlmutter, MD

314-362-6026perlmutterjoel@wustl.edu

Principal Investigator:

Joel S Perlmutter, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erin Schubert

215-662-3041erinshu@pennmedicine.upenn.edu

Ilya Nasrallah, MD, PhD

ilya.nasrallah@pennmedicine.upenn.edu

Principal Investigator:

IIya Nasrallah, MD, PhD

More Information

Sponsor

University of Pennsylvania

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Positron Emission Tomography (PET)
  • Brain MRI
  • Parkinson's disease (PD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-04-24.