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

ConditionTauopathies
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40-85
SponsorUniversity of Pennsylvania

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: 11C-M503 PETExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Organ Biodistribution or Dosimetry

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.

Time frame
4 weeks
2

PET Uptake of Tracer

Determine whether there is selective uptake of 11C-M503 in people with MSA compared to healthy volunteers, PD and PSP participants.

Time frame
4 weeks

Secondary outcomes

1

Adverse Events

Adverse events will be collected.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
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