AI-PROGNOSIS_D5.5 / Study initiation package (AI-PMP study)

Executive summary D5.5 “Study Initiation Package (AI-PMP Study)” provides the finalised documentation required for the set-up, initiation, and compliant conduct of the AI-PMP clinical study, including the study protocol, the informed consent form to be signed by participants, the Standard Operating Procedures (SOPs), the laboratory manual, and the GDPR-compliant data management infrastructure. It also outlines the OpenClinica electronic clinical data capture system, lists the study registration on ClinicalTrials.gov (NCT06444789), and includes the ethics approval status across sites, along with the letters from the respective local ethics committees (with submission pending at the last of the four sites, QMUL in the UK). The AI-PMP study aims to establish proof-of-concept for two AI-driven multivariable prognostic models for disease progression and medication response, integrating clinical, demographic, lifestyle, genetic, and digital biomarker (dBM) data, to enhance clinical decision-making in Parkinson’s disease (PD). Model development leveraged existing databases and biobanks and their operationalisation is supported by two novel digital health tools developed within AI-PROGNOSIS, the mAI-Care mobile app for patient self-logging and smartwatch data capturing, and the mAI-Insights platform for clinician data entry and data-driven insights. Importantly, the AI-PMP study serves as a translational bridge between predictive modelling and clinical validation, supporting the broader mission of AI-PROGNOSIS to deliver personalized, data-driven care pathways for PD.