Investigating a new radiotracer for brain imaging in Parkinson's disease and related conditions
Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-M503
This study is testing a new brain imaging tool to see if it can help identify abnormal protein deposits in the brains of people with Parkinson's disease and similar conditions.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 3 sites (New Haven, Connecticut and 2 other locations) |
| Trial ID | NCT06303921 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the biodistribution, metabolism, excretion, and brain uptake of the radiotracer 11C-M503, which is designed to quantify abnormal alpha-synuclein deposits in the brains of individuals with Parkinson's disease (PD). Participants will include those diagnosed with PD, multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and healthy controls, with a total of up to 70 participants recruited across multiple clinical sites. The study will utilize advanced imaging techniques such as PET and MRI to gather data on brain activity and pathology. The findings may help differentiate between various tauopathies and improve understanding of these neurodegenerative conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 40 to 85 with a clinical diagnosis of Parkinson's disease, multiple system atrophy, progressive supranuclear palsy, or healthy controls.
Not a fit: Patients who are pregnant or breastfeeding, as well as those unable to provide informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for Parkinson's disease and related disorders, enhancing patient care.
How similar studies have performed: Other studies utilizing similar imaging techniques have shown promise in understanding neurodegenerative diseases, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients in all cohorts will be male or female adults from 40 to 85 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 * Investigators 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 -M503, 11C-PiB or 18F-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 * 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
New Haven, Connecticut and 2 other locations
- Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Ilya M Nasrallah, MD, PhD — University of Pennsylvania
- Study coordinator: Erin Schubert
- Email: erinshu@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.