RecruitingEarly Phase 1NCT06932809

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

Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 18F-JSS20-183A

Sponsor

University of Pennsylvania

Enrollment

90 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Tauopathies

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

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This is a specialized research study that tracks how a specific drug is absorbed, broken down, and removed from the body — and how much of it reaches the brain. Participants will receive the drug and undergo detailed testing including blood samples and brain scans to understand its behavior in the body. **You may be eligible if...** - You meet specific health criteria set by the research team - You are an adult willing to undergo blood sampling and imaging studies - You are not taking medications that could interfere with the study drug **You may NOT be eligible if...** - You have significant liver or kidney disease - You take medications that strongly affect drug metabolism (such as certain antifungals or antibiotics) - You are pregnant or breastfeeding - You have a history of drug or alcohol dependence - You have had certain brain conditions or surgeries Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG18F-JSS20-183A PET

2 hour Positron Emission Tomography (PET) scan using new radiotracer 18F-JSS20-183A.

DIAGNOSTIC_TESTBrain MRI

MRI scan of the brain.

DIAGNOSTIC_TESTAmyloid PET

PET scan with Florbetaben F18 or 11C-PiB.

BEHAVIORALNeurological Assessments

Neurological assessments, including a video interview.

Locations(2)

University of California

San Francisco, California, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT06932809

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