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

ConditionTauopathies
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

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 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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: 11C-HY-2-15 PETExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Organ biodistribution

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

Time frame
4 weeks
2

PET uptake of tracer

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

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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