Open-label Study to Evaluate Brain α-Synuclein Deposition Using PET and [18F]MK-0947 in Parkinson’s Disease

Description

This Phase 1, open-label study will evaluate the safety, pharmacokinetics, and imaging characteristics of [18F]MK-0947, a novel PET tracer targeting α-synuclein pathology in Parkinson’s disease (PD). The study consists of two parts: Part 1 includes PD and healthy elderly participants for brain imaging using standard and high-resolution PET scanners; Part 2 includes healthy participants for whole-body dosimetry to estimate radiation exposure. Imaging sessions will involve dynamic PET scans lasting up to 2 hours, arterial or venous blood sampling for kinetic modeling, and MRI for anatomical co-registration. Safety assessments include vital signs, ECGs, laboratory tests, and adverse event monitoring. The investigational tracer will be administered intravenously at doses up to 10 mCi, with strict adherence to radiation safety guidelines. Data will be analyzed using compartmental and graphical modeling approaches to derive quantitative metrics such as SUV, SUVR, VT, and DVR. This study aims to establish proof of concept for [18F]MK-0947 as a biomarker for α-synuclein pathology, supporting future therapeutic trials and advancing diagnostic capabilities for synucleinopathies.