Long-Term Imaging Study of Early Parkinsons Disease Using 18F AV-133 Tracking Prodromal Parkinsons Disease Progression Over 24 Months

What this Trial Is About

Researchers are investigating Prodromal Parkinsons Disease by studying the progression of 18F AV-133 PET imaging in participants who show early signs of Parkinsons but have not yet developed typical symptoms. This observational study is part of the Parkinsons Progression Marker Initiative PPMI, aiming to identify biomarkers that signal disease progression and help improve future treatments. The study is international and multi-center, with participants followed for up to 24 months to better understand the disease course during this early stage. Participants will undergo three 18F AV-133 PET imaging scans targeting the vesicular monoamine transporter at the beginning of the study, at 12 months, and at 24 months. Approximately 100 prodromal Parkinsons participants enrolled in the PPMI Clinical 002 study will receive these imaging procedures at up to 10 sites. The study focuses on monitoring changes over time through this specialized imaging technique. During the study, participants will have comprehensive assessments including motor, neuropsychiatric, cognitive, imaging, and biomarker evaluations based on the PPMI Clinical protocol. Researchers will measure the mean rate of change and variability in 18F AV-133 imaging over 24 months, along with clinical motor and cognitive progression and correlations with other clinical and imaging outcomes. Safety will also be monitored by tracking treatment-emergent adverse events throughout the 24-month follow-up period.

Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)