Recruiting
Early Phase 1

11C-HY-2-15

Sponsor:

University of Pennsylvania

Code:

NCT06032026

Conditions

Tauopathies

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

11C-HY-2-15 PET

brain MRI

Amyloid PET scan

Neurological assessments

Study Details

Brief summary:

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.

Conditions

Tauopathies

Study ID

NCT06032026

Start date

Jul 20, 2023

Status verified date

Nov, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • The entire cohort will include men and women clinically diagnosed with MSA, PD, PSP or are healthy controls. A sub-set of these participants who undergo whole body scanning that will be used for analysis of biodistribution and dosimetry calculations.
  • Patients in all cohorts will be male or female adults from 40 to 80 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
  • We will ask PD/MSA/PSP 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 for diagnostic agreement (PD, MSA, PSP or Healthy Control)

Exclusion Criteria:

  • 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 11C HY-2-15, 11C-PiB or Florbetaben
  • Forms of parkinsonism other than PD, PSP and MSA as defined above
  • Major psychiatric disorder (e.g. schizophrenia or bipolar disorder) - major depressive disorder is allowed
  • 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
  • PSP and MSA subjects will be excluded if they have a history of any prior positive ß-amyloid PET scan or positive CSF AD biomarkers.
  • 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

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

11C-HY-2-15 PET

2 hour Positron Emission Tomography (PET) scan using new radiotracer 11C-HY-2-15

brain MRI

brain MRI scan

Amyloid PET scan

PET scan with Florbetaben F18 or 11C-PiB

Neurological assessments

Neurological assessments, including video interview

Primary outcome measure

  • Organ biodistribution [ Time Frame: 4 weeks ]
  • PET uptake of tracer [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Erin o Schubert

215-662-3041erinschu@pennmedicine.upenn.edu

Mary Hansbury

215-746-8192mary.hansbury@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erin Schubert

215-662-3041erinschu@pennmedicine.upenn.edu

Principal Investigator:

Ilya Nasrallah, MD, PhD

More Information

Sponsor

University of Pennsylvania

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Keywords

  • Alpha synuclein
  • Positron Emission Tomography (PET)
  • brain MRI

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 2025-11-19.