Status:
RECRUITING
Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15
Lead Sponsor:
University of Pennsylvania
Conditions:
Tauopathies
Eligibility:
All Genders
40-80 years
Phase:
EARLY_PHASE1
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 deposite...
Detailed Description
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 deposite...
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.
- Diagnosis-specific inclusion criteria: Clinical diagnoses will be determined by consensus committee for diagnostic agreement (PD, MSA, PSP or Healthy Control)
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
Key Trial Info
Start Date :
July 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06032026
Start Date
July 20 2023
End Date
July 31 2028
Last Update
November 19 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104