Exploring the Use of Alpha-synuclein Assays for Translational Biomarkers and Pharmaceutical Intervention Trials

Study Rationale:
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease. The biggest roadblock facing the development of disease-modifying therapies is the lack of reliable biomarkers (trackers of disease activity), which affects the reliability of clinical trials. Thus, the development of a simple diagnostic test to aid in the clinical diagnosis of PD is of great importance. A growing body of evidence indicates that alpha-synuclein (sticky protein that clumps in the brains of those with PD) oligomers (molecules composed of a small number of units) are most promising biomarker candidates for the detection of PD. Therefore, the goal of the proposed study is to validate our oligomeric alpha-synuclein specific assay (test) as diagnostic tool for Parkinson's.

Hypothesis:
To explore whether our oligomeric alpha-synuclein specific ELISA (technique used to detect proteins) can be used as a research tool to address the unmet need for reliable biomarkers of PD.

Study Design:
Using our oligomeric alpha-synuclein-specific antibody, we have generated and validated an ELISA assay that can specifically measure alpha-synuclein oligomers in biological samples. This assay will be validated in the lab of Dr. Omar El-Agnaf, as well as in two other labs (at Biolegend and Lundbeck), in both cerebrospinal fluid (baths the brain and spinal cord) and blood samples from one group of research participants.

Impact on Diagnosis/Treatment of Parkinson's disease:
Our project aims to validate an ELISA assay that holds the potential for accurate assessment of alpha-synuclein oligomers in biological fluids to detect Parkinson's. This research tool could aid in the detection of early-stage PD and could help monitor response to treatments.

Next Steps for Development:
Upon validation, our assay may be utilized to explore the potential of alpha-synuclein oligomers for the diagnosis and prognosis of Parkinson's in well-controlled prospective and longitudinal studies.