Recruiting
Early Phase 1

18F-JSS20-183A

Sponsor:

University of Pennsylvania

Code:

NCT06932809

Conditions

Tauopathies

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

18F-JSS20-183A PET

Brain MRI

Amyloid PET

Neurological Assessments

Study Details

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.

Conditions

Tauopathies

Study ID

NCT06932809

Start date

May 9, 2025

Status verified date

Dec, 2025

Completion date

Apr, 2030

Anticipated

Primary completion date

Apr, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

18F-JSS20-183A PET

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

Brain MRI

MRI scan of the brain.

Amyloid PET

PET scan with Florbetaben F18 or 11C-PiB.

Neurological Assessments

Neurological assessments, including a video interview.

Primary outcome measure

  • Organ Biodistribution or Dosimetry [ Time Frame: 4 weeks ]
  • PET Uptake of Tracer [ Time Frame: 4 weeks ]

Central Contacts and Locations

Locations

University of California

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Gil Rabinovici

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Ilya Nasrallah, MD, PhD

More Information

Sponsor

University of Pennsylvania

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Keywords

  • Positron Emission Tomography (PET)
  • Brain MRI
  • Parkinsons Disease (PD)
  • Alzheimers Disease (AD)
  • Progressive Supranuclear Palsy (PSP)
  • Corticobasal Syndrome (CBS)
  • Genetic Frontotemporal Lobar Degeneration (Genetic FTLD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-12-23.