Investigating a new radiotracer for brain imaging in Parkinson's disease and related conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the biodistribution, metabolism, excretion, and brain uptake of the radiotracer 11C-M503, which is designed to quantify abnormal alpha-synuclein deposits in the brains of individuals with Parkinson's disease (PD). Participants will include those diagnosed with PD, multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and healthy controls, with a total of up to 70 participants recruited across multiple clinical sites. The study will utilize advanced imaging techniques such as PET and MRI to gather data on brain activity and pathology. The findings may help differentiate between various tauopathies and improve understanding of these neurodegenerative conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Washington University in St. Louis
  St Louis, Missouri, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Ilya M Nasrallah, MD, PhD — University of Pennsylvania
• Study coordinator: Erin Schubert
• Email: erinshu@pennmedicine.upenn.edu
• Phone: 215-662-3041

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.