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Study of 11C-HY-2-15 for Tauopathies

This study is looking at a new imaging agent called 11C-HY-2-15. The goal is to see how this agent spreads in the body, how it's processed, how it leaves the body, and how much of it goes into the brain. Researchers want to use 11C-HY-2-15 to measure a protein called alpha-synuclein, which builds up abnormally in the brains of people with Multiple System Atrophy (MSA). They will compare how 11C-HY-2-15 is taken up in people with MSA, Parkinson's disease (PD), and progressive supranuclear palsy (PSP), as well as healthy volunteers. You may be able to join if you are between 40 and 80 years old and have been diagnosed with MSA, PD, PSP, or are a healthy control. The study aims to understand how 11C-HY-2-15 moves through the body and into the brain.

Study design
This study plans to enroll up to 70 participants, including people with MSA, PD, PSP, and healthy controls. It is a multi-center project.
What's involved
You would undergo a 2-hour PET scan using 11C-HY-2-15, a brain MRI scan, an Amyloid PET scan, and neurological assessments, including a video interview.
Compensation
Not stated in the trial record.
Follow-up
Your organ biodistribution and PET uptake of the tracer will be measured at 4 weeks after the scan.

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NCT06032026

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

Recruiting
EARLY_PHASE1Ages 40–80InterventionalDiagnostic
University of Pennsylvania
~70 participants
Updated 2025-11-19 on ClinicalTrials.gov
What's tested:11C-HY-2-15 PETbrain MRIAmyloid PET scanNeurological assessments

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Organ biodistribution
Measured over 4 weeks
+1 more outcome measured

Conditions

Tauopathies

Explore related trials

Multiple System AtrophyParkinson DiseaseProgressive Supranuclear Palsy

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Ilya Nasrallah, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

Erin o Schubert
[email protected]
215-662-3041
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

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 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

What this trial measures

  • Organ biodistribution4 weeks

    Determine biodistribution of the radioactive investigational drug, 11C HY-2-15

  • PET uptake of tracer4 weeks

    Determine whether there is selective uptake of 11C HY-2-15 in people with MSA compared to healthy volunteers, PD and PSP participants