Study Rationale: The clinical phase of Parkinson’s disease (PD) is preceded by a prodromal phase of progressing neurodegeneration that can last many years. Imaging markers such as radiolabeled AV-133 have been used to quantify changes in dopamine packaging in the brains of people with PD. In this study, we will use AV-133 imaging to assess disease progression over time in people in the clinical and prodromal phases of PD. The ability to identify potential prodromal PD subtypes and to better understand variability at this stage of the disease will be crucial for early and accurate diagnosis and for targeting of neuroprotective interventions.
Hypothesis: We hypothesize that AV-133 imaging will allow us to track changes in the packaging of dopamine over time in different brain regions of people with PD and prodromal PD. We can then compare these images to clinical and fluid biomarker outcomes.
Study Design: We will recruit approximately 30 people with PD and 30 participants with prodromal PD for this longitudinal study. All participants will be comprehensively assessed at baseline and every 12 months thereafter. Over the course of 24 months, we will conduct imaging assessments with [18F] AV-133, perform motor, neuropsychiatric and cognitive clinical assessments, and collect biospecimens for analysis. We will use uniformly established protocols to collect data, which will be stored and analyzed at designated core facilities.
Impact on Diagnosis/Treatment of Parkinson’s disease: If successful, our results will provide a better understanding of the prodromal phase of PD and how it differs from the later stage of the disease. Understanding those differences will facilitate the development of new therapies.
Next Steps for Development: Although this study will be performed in a single imaging center in mainland China, we expect to expand it to additional locations and to increase the number of participants to better enable identification of potential prodromal subtypes.