Study of Biodistribution, Metabolism, Excretion and Brain Uptake 18F-JSS20-183A

Launched by UNIVERSITY OF PENNSYLVANIA · Apr 10, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 18F-JSS20-183A, is looking to understand how a new imaging agent works in the brain. This agent is specially designed to detect a protein called 4Repeat Tau (4Rtau), which can build up abnormally in the brains of people with certain neurodegenerative diseases, such as Progressive Supranuclear Palsy (PSP), Corticobasal Syndrome (CBS), and Alzheimer's Disease (AD). The trial is taking place at several locations, including the University of Pennsylvania, and is currently recruiting adult participants aged 40 to 85 who have these conditions or are healthy controls.

To be eligible, participants must be willing to provide informed consent and agree to the study procedures. They should not be pregnant, breastfeeding, or have certain other medical conditions that could affect their safety during the study. Participants can expect to undergo imaging tests to see how the new agent behaves in their body and brain. While it is helpful for the study to have brain donation from participants after their passing, this is not a requirement for taking part. Overall, this study aims to improve our understanding of tau-related diseases and may help in developing better treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients in all cohorts will be male or female adults from 40 to 85 years of age.
• • 2. 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 disease cohort 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 (except AD and HC cohorts) for diagnostic agreement using video exams of each participant that are stored at WashU in a secured video repository with view-only access exclusively by secured virtual private network (VPN) connection. Video exam and screening assessments for PSP, CBS, MSA, PD, and FTLD may not be required to be repeated if they have been done within 6 months of enrollment, unless requested at the discretion of an investigator to document changes in clinical progression. A consensus committee will not be required to be repeated for participants who have already had a consensus committee diagnosis documented.
• Exclusion Criteria:
• • 1. 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 18F-JSS20-183A 11C-PiB or 18F-Florbetaben
• • 2. Forms of parkinsonism other than PSP-RS, and PD as defined above
• • 3. History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
• • 4. Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician
• • 5. Contraindication to MRI, such as non-compatible implanted medical device
• • 6. 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