Study Rationale:
Lewy bodies composed primarily of the protein alpha-synuclein are important hallmarks of Parkinson’s disease (PD). Available data on the clinical use of alpha-synuclein in PD have shown mixed results, in part due to methodological complexities or to the level of assay standardization. No company has taken yet the effort to translate these exploratory results obtained with research use-only assays (first generation) to a more robust in vitro diagnostic use product (second generation).
Hypothesis:
ADx NeuroSciences will develop new, robust assays for alpha-synuclein and harmonize results between studies and technologies.
Study Design:
Using combinations of monoclonal antibodies, ADx will develop assays to quantify alpha-synuclein in cerebrospinal fluid and blood. After obtaining proof-of-concept, the prototype test will be further developed into a robust assay. Special attention will be given to high precision, accurate values, understanding of the presence of confounding factors, reduction of issues linked to absorption of alpha-synuclein to recipients, extensive characterization of the nature of the analyte in the sample (e.g., whole protein, modified forms, aggregated isoforms).
Impact on Diagnosis/Treatment of Parkinson’s Disease:
The ultimate goal will be to use measurement of alpha-synuclein as a diagnostic tool for earlier PD identification and intervention and for clinical trial design.
Next Steps for Development:
The availability of a robust, second generation assay will allow its integration into large-scale clinical studies by pharmaceutical companies and consortia, which will further validate and create wide acceptance by the authorities and by neurologists for the measurement of alpha-synuclein as an important improvement in the diagnosis of Parkinson’s disease.