Research on Brain Imaging for Neurodegenerative Disorders
Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503
Recruiting
Early Phase 1Interventional Study
Tauopathies
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 85
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
70 (estimated)
Sponsor
University of Pennsylvania · Other
Who this trial is looking for
This trial is looking for adults aged 40 to 85 to study how a special imaging agent works in the brain. Participants will provide consent to take part in the research and may be asked about donating their brain after passing away, but this is not required.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 40 and 85 years old.
I can provide informed consent for myself.
I have a diagnosis of Parkinson's disease, multiple system atrophy, progressive supranuclear palsy, or am a healthy control.
You may not be able to join if
I am pregnant or breastfeeding.
I have a major psychiatric disorder.
I have a history of significant alcohol or substance abuse.
I cannot tolerate imaging or blood procedures.
I have a current medical condition that could affect my safety in the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
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Eligibility Criteria
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 f…
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
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