During the first reporting period, the consortium established the scientific, clinical and organisational foundations required to develop and evaluate the proposed diagnostic approach. Common procedures were developed for patient selection, sample collection, processing, storage and analysis, and work progressed on ethics, regulatory and contractual requirements at the participating centres.
The consortium also defined the clinical groups needed to assess the diagnostic tools, including PD subjects, relevant neurological comparison groups and controls. Clinical and biomarker data structures were established to support harmonised data collection and later integration of laboratory and clinical results.
Technical work focused on the development and evaluation of reagents targeting disease-associated forms of alpha-synuclein, together with methods for the enrichment, isolation and characterisation of extracellular vesicles, including vesicle populations associated with the nervous system. Candidate antibodies and assay configurations were generated, screened or characterised according to predefined analytical criteria, most especially sensitivity, specificity, reproducibility and compatibility with clinically available blood samples.
In parallel, the project advanced complementary biomarker and data-analysis activities. Quality-control, data-governance and analysis procedures were established, and clinical and laboratory datasets are being prepared for integrated statistical and computational analysis.
The main achievements of the period include the establishment of a functioning multicentre framework, harmonisation of key procedures, advancement of candidate antibodies and extracellular-vesicle methods, and creation of the data infrastructure required for biomarker evaluation. By the end of the reporting period, all clinical sites had been activated, participants and samples collection has started, and prototype configurations had progressed to further evaluation.
