Study Rationale: Seed Amplification Assays (SAA) have shown impressive results in distinguishing people with Parkinson's disease from healthy individuals using a simple yes/no test. This test detects harmful forms of a protein called alpha-synuclein. The goal of this project is to develop a test that goes beyond the yes/no answer and also measures the amount of this protein. This can help track the progression of Parkinson’s disease and the effectiveness of treatment. We plan to explore three novel technological advancements, including a digital version of the advanced quantitative SAA test.
Hypothesis: We aim to create an alpha-synuclein SAA that can measure disease progression and that can evaluate treatment success. By using one or more of our new methods, we hope to accurately detect the range of harmful alpha-synuclein proteins in human samples.
Study Design: First, we will study how different materials, setups, and methods affect the SAA test. This will help us to better understand the complex assay. Our long standing experience with chemistry, biology, medicine, and technology will support this research. Finally, we will adapt our digital assay technologies to improve the test, allowing for more accurate ways to estimate the concentration of alpha-synuclein pathology. We will then apply the successful methods to unique and well-studied groups of patients and controls, including also those from clinical trials.
Impact on Diagnosis/Treatment of Parkinson’s disease: The new test will help determine the biological stage of Parkinson's disease and allows for monitoring treatment effects by accurately measuring harmful protein levels. Strict control of the test quality will ensure that the results are consistent and comparable in long-term use and across labs worldwide.
Next Steps for Development: We will expand the fields of research and scope of applications on existing samples from large clinical studies. Such research will provide further evidence for the clinical usefulness of the novel, quantitative SAA for people with Parkinson’s disease.