NCT06932809 · Early Phase 1 · RECRUITING

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

This study tests a new imaging tracer, 18F-JSS20-183A, for PET scans. Researchers want to see where it travels in the body, how it breaks down, and how much reaches the brain. The goal is a way to see a type of tau protein called 4R tau. It is an early Phase 1 study, meaning a first look at safety and behavior, not a treatment.

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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-12-23

View full record on ClinicalTrials.gov

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