Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15

• Status: Recruiting
• Trial end date: 2028-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C HY-2-15. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Multiple System Atrophy (MSA). The investigators will compare uptake in people with MSA with people with Parkinson disease (PD) and progressive supranuclear palsy (PSP) as well as healthy 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) (not a 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania

Criteria

Inclusion Criteria:

• The entire cohort will include men and women clinically diagnosed with MSA, PD, PSP or are healthy controls. A sub-set of these participants who undergo whole body scanning that will be used for analysis of biodistribution and dosimetry calculations.

• Patients in all cohorts will be male or female adults from 40 to 80 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

• We 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 HY-2-15, 11C-PiB or 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

• History of any prior positive ß-amyloid PET scan or positive CSF AD biomarkers.

• 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