Status:
RECRUITING
Study of Biodistribution, Metabolism, Excretion and Brain Uptake 18F-JSS20-183A
Lead Sponsor:
University of Pennsylvania
Conditions:
Tauopathies
Eligibility:
All Genders
40-85 years
Phase:
EARLY_PHASE1
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 abno...
Detailed Description
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 abno...
Eligibility Criteria
Inclusion
- Patients in all cohorts will be male or female adults from 40 to 85 years of age.
- 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
- 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
- Forms of parkinsonism other than PSP-RS, and PD as defined above
- History of significant or ongoing alcohol abuse or substance abuse or dependence based on medical record review or self-reported
- Contraindications or inability to tolerate imaging, arterial line or IV placement or blood draw procedures in the opinion of an investigator or treating physician
- Contraindication to MRI, such as non-compatible implanted medical device
- 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
Key Trial Info
Start Date :
May 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06932809
Start Date
May 9 2025
End Date
April 1 2030
Last Update
December 23 2025
Active Locations (2)
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1
University of California
San Francisco, California, United States, 94143
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104