Image abnormal brain protein deposits

Trial ID
NCT06303921
Official Title
Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-M503
Goal
Image abnormal brain protein deposits
Phase
EARLY_PHASE1
Status
RECRUITING
Sponsor
University of Pennsylvania
Study Type
INTERVENTIONAL
Enrollment
70 participants
Conditions
Tauopathies
Interventions
11C-M503 PET, Brain MRI, Amyloid PET, Neurological assessments

Plain-Language Summary

Goal: The team is testing whether a new PET tracer, 11C-M503, can safely reach the brain and highlight abnormal protein deposits like tau that are linked to PSP, MSA, and other tauopathies. Approach: Participants will have PET scans with 11C-M503 plus MRI, amyloid PET and neurological exams while researchers measure how the tracer is distributed, metabolized, excreted, and taken up in the brain; 11C-M503 is a radioactive imaging ligand meant to reveal protein aggregates and is diagnostic only, so it should not affect treatments like levodopa. Eligibility: Adults aged 40 to 85 are being enrolled, including people with clinical diagnoses of Parkinson disease, MSA, PSP, and healthy controls, who can provide consent or have a study partner; pregnant or breastfeeding women are excluded.

Locations

  • Yale New Haven Hospital, New Haven, Connecticut, United States
  • Washington University in St. Louis, St Louis, Missouri, United States
  • University of Pennsylvania, Philadelphia, Pennsylvania, United States

Frequently Asked Questions

What is this trial testing?
This trial is studying 11C-M503 PET. Goal: The team is testing whether a new PET tracer, 11C-M503, can safely reach the brain and highlight abnormal protein deposits like tau that are linked to PSP, MSA, and other tauopathies. Approach: Participants will have PET scans with 11C-M503 plus MRI, amyloid PET and neurological exams while researchers measure how the tracer is distributed, metabolized, excreted, and taken up in the brain; 11C-M503 is a radioactive imaging ligand meant to reveal protein aggregates and is diagnostic only, so it should not affect treatments like levodopa. Eligibility: Adults aged 40 to 85 are being enrolled, including people with clinical diagnoses of Parkinson disease, MSA, PSP, and healthy controls, who can provide consent or have a study partner; pregnant or breastfeeding women are excluded.
Who can participate?
Participants must be between 40 Years and 85 Years.
Where is this trial located?
This trial is recruiting at 3 locations.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This Phase 1 trial is estimated to last approximately 5 years.

View on ClinicalTrials.gov