Investigating brain uptake of a new radiotracer in tauopathies
Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-HY-2-15
This study is testing a new brain imaging tool to see how well it can detect abnormal protein deposits in the brains of people with Multiple System Atrophy, Parkinson's disease, and progressive supranuclear palsy, compared to healthy individuals.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06032026 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the biodistribution, metabolism, excretion, and brain uptake of the radiotracer 11C-HY-2-15, which is designed to quantify abnormal alpha-synuclein deposits in the brains of individuals with Multiple System Atrophy (MSA). Participants will include those diagnosed with MSA, Parkinson's disease (PD), progressive supranuclear palsy (PSP), and healthy controls, with a total of up to 70 participants recruited across multiple sites. The study will involve dynamic brain PET scanning and neurological assessments to compare the uptake of the radiotracer among different groups. The University of Pennsylvania will lead the project, collaborating with several other institutions for participant recruitment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 40 to 80 years with a clinical diagnosis of MSA, PD, PSP, or healthy controls.
Not a fit: Patients with conditions unrelated to tauopathies or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of tauopathies and improve diagnostic methods for conditions like MSA and PD.
How similar studies have performed: Other studies using similar PET imaging approaches have shown promise in understanding neurodegenerative diseases, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Ilya Nasrallah, MD — University of Pennsylvania
- Study coordinator: Erin o Schubert
- Email: erinschu@pennmedicine.upenn.edu
- Phone: 215-662-3041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.