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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Pennsylvania
Study ID
NCT06932809
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Tauopathies

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • 18F-JSS20-183A PET — DRUG
    2 hour Positron Emission Tomography (PET) scan using new radiotracer 18F-JSS20-183A.
  • Brain MRI — DIAGNOSTIC_TEST
    MRI scan of the brain.
  • Amyloid PET — DIAGNOSTIC_TEST
    PET scan with Florbetaben F18 or 11C-PiB.
  • Neurological Assessments — BEHAVIORAL
    Neurological assessments, including a video interview.

Study Details

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.

Key Dates

Start date
May 9, 2025
Status verified
Dec 2025
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 18F-JSS20-183A PET
    Participants will undergo 18F-JSS20-183A PET scan, they may also have a brain MRI and Amyloid PET scan as well as neurological assessments.

Primary Outcome Measure

Organ Biodistribution or Dosimetry [ Time Frame: 4 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan FranciscoCalifornia94143
Karen Smith
[email protected]
415-514-7386
Carol Soppe
[email protected]
415-514-7386
Gil Rabinovici (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Erin Schubert
[email protected]
215-662-3041
Ilya Nasrallah, MD, PhD
[email protected]
Ilya Nasrallah, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
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