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

Launched by UNIVERSITY OF PENNSYLVANIA · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special imaging agent called 11C-M503, which helps researchers understand how certain proteins, specifically alpha-synuclein, behave in the brains of people with conditions like Parkinson's disease, multiple system atrophy, and progressive supranuclear palsy. The goal is to see how this agent spreads in the body, how it is processed, and how it gets into the brain. By comparing participants with these conditions to healthy volunteers, scientists hope to learn more about these diseases and improve diagnosis and treatment.

To join the study, participants need to be adults between 40 and 85 years old, and they must be able to give informed consent, meaning they understand what the study involves. It’s important to note that while participants with Parkinson's disease, multiple system atrophy, or progressive supranuclear palsy are encouraged to join, agreeing to donate their brain after passing is optional. Participants can expect to undergo imaging tests and other assessments at various research centers, and they will be closely monitored to ensure their safety throughout the study.

Gender

ALL

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 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