Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06032026
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Tauopathies

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • 11C-HY-2-15 PET — DRUG
    2 hour Positron Emission Tomography (PET) scan using new radiotracer 11C-HY-2-15
  • brain MRI — DIAGNOSTIC_TEST
    brain MRI scan
  • Amyloid PET scan — DIAGNOSTIC_TEST
    PET scan with Florbetaben F18 or 11C-PiB
  • Neurological assessments — BEHAVIORAL
    Neurological assessments, including video interview

Study Details

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C HY-2-15. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Multiple System Atrophy (MSA). The investigators will compare uptake in people with MSA with people with Parkinson disease (PD) and progressive supranuclear palsy (PSP) as well as healthy volunteers. 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) (not a clinical site), Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). 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
Jul 20, 2023
Status verified
Nov 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

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

Arms

  • Experimental: 11C-HY-2-15 PET
    Participants will undergo 11C-HY-2-15 PET scan, they may also have a brain MRI and Amyloid PET scan as well as neurological assessments

Primary Outcome Measure

Organ biodistribution [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Erin Schubert
[email protected]
215-662-3041
Ilya Nasrallah, MD, PhD (PRINCIPAL_INVESTIGATOR)

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University of Pennsylvania· Philadelphia, PA

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