Study of FMODAG-009 PET Imaging to Assess Brain Changes in Parkinsons Disease, Multiple System Atrophy, and Healthy Adults

What this Trial Is About

This research aims to evaluate the imaging features and safety of the investigational drug FMODAG-009 in people with Parkinsons disease PD, Multiple System Atrophy MSA, and healthy adults. The study is early phase 1, open-label, and conducted at a single center, involving about 13 participants. It leverages existing data from the PPMI 002 study for PD and healthy controls to reduce participant burden and aligns with established assessments. Participants will receive a single intravenous injection of up to 8 mCi of FMODAG-009. After the injection, they will undergo dynamic PET brain imaging using the United Imaging NeuroEXPLORER NX scanner for up to 3 hours. Structural MRI scans, either previously obtained or from routine care, will help localize brain regions. Safety monitoring includes physical exams, vital signs, ECG, lab tests, and adverse event tracking on the imaging day and at a follow-up contact 2 to 3 business days later. Blood samples will be collected to analyze radiometabolites and support PET data interpretation. Throughout the study, participants clinical and biomarker data from prior assessments will be used when available. Safety assessments continue shortly after imaging to monitor tolerability. Researchers will measure brain uptake of the tracer using Standard Uptake Value Ratios SUVR up to 3 hours post-injection. The study will last from screening through follow-up contact, ending about 2 to 3 business days after the imaging procedure.

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