NCT06932809 Study of Biodistribution, Metabolism, Excretion and Brain Uptake 18F-JSS20-183A
| NCT ID | NCT06932809 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Pennsylvania |
| Condition | Tauopathies |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-05-09 |
| Primary Completion | 2030-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2025-05-09 with a primary completion date of 2030-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 18F-JSS20-183A. The goal of this radiotracer is to quantify 4Repeat Tau (4Rtau) protein that is abnormally deposited in the brain of people with a class of neurodegenerative diseases called tauopathies, such as Progressive Supranuclear Palsy (PSP), Corticobasal Syndrome (CBS), syndromes of genetic Frontotemporal Lobar Degeneration (genetic FTLD) as well as participants with Parkinson disease (PD), Alzheimer's Disease (AD) and healthy controls. 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), Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WUSTL). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites.
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
Frequently Asked Questions
Who can join the NCT06932809 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Tauopathies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06932809 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06932809 currently recruiting?
Yes, NCT06932809 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Pennsylvania to inquire about joining.
Where is the NCT06932809 trial being conducted?
This trial is being conducted at San Francisco, United States, Philadelphia, United States.
Who is sponsoring the NCT06932809 clinical trial?
NCT06932809 is sponsored by University of Pennsylvania. The trial plans to enroll 90 participants.