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

ConditionTauopathies
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40-85
SponsorUniversity of Pennsylvania

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: 18F-JSS20-183A PETExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Organ Biodistribution or Dosimetry

Determine biodistribution of the radioactive investigational drug, 18F-JSS20-183A and calculate human dosimetry. A second IV or an arterial line may be placed in the arm contralateral to the side of injection for blood metabolite analysis and/or radioactive counts at various times during the scanning session. Biodistribution, metabolism, excretion and pilot brain uptake data will be collected and human dosimetry will be calculated.

Time frame
4 weeks
2

PET Uptake of Tracer

Determine whether there is selective uptake of 18F-JSS20-183A in people with taupathies compared to healthy volunteers and non-tau depositing neurodegenerative disease.

Time frame
4 weeks

Secondary outcomes

1

Adverse Events

Adverse events will be collected.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
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