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

Launched by UNIVERSITY OF PENNSYLVANIA · Sep 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a special imaging agent called 11C-HY-2-15, which helps researchers see how a protein called alpha-synuclein behaves in the brains of people with certain conditions like Multiple System Atrophy (MSA), Parkinson's Disease (PD), and Progressive Supranuclear Palsy (PSP). The goal is to understand how this protein is distributed, how the body processes it, and how well it gets into the brain compared to healthy individuals. By comparing these different groups, the researchers hope to gain insights that could help with diagnosing and treating these conditions.

To be part of the study, participants need to be adults aged 40 to 80 who have been diagnosed with MSA, PD, PSP, or are healthy volunteers. Participants will need to agree to take part in the study and may be asked to donate brain tissue after they pass away, but this is not required to join. Throughout the study, participants can expect to undergo imaging tests and other assessments to help gather important information. It's important to note that certain individuals, such as pregnant or breastfeeding women and those with certain medical conditions, won't be eligible to participate for safety reasons.

Gender

ALL

Eligibility 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
• • PSP and MSA subjects will be excluded if they have a 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