– SIGNATURE

Background: Harmonisation of phenotype data collection including clinical-neuropsychological information in neurocognitive disorders (NCDs) has become an urgent priority for a better use of big data analysis and for creating solid large clinical data registries aimed at individualised precision medicine interventions. The use of cognitive markers in NCDs has radically changed due to the translation from clinical-neuropsychological to clinical-biological frameworks. While they cannot be regarded as proper biomarkers of underlying pathologies, they can be useful gatekeepers for better use of invasive and/or expansive biological markers, suggesting increased probability of disease. In addition, neuropsychological testing plays a major role in staging and prognosis of NCDs by documenting cognitive-behavioural changes and daily-life functional impairments. The international SIGNATURE consortium initiative involving more than 80 centres from 17 countries has been launched with the aim to harmonise socio-cognitive assessment in NCDs. While the DSM-5 recognizes the relevance of social behaviour and socio-affective changes in NCDs, this domain is not systematically investigated in practice. Objectives: Starting from the SIGNATURE network, this proposal is aimed to: i) establish best-practice guidelines for the implementation of socio-cognitive tasks in European memory clinics based on clinicians’ & stakeholders’ needs; ii) define stakeholders’ recommendations for the real-life effectiveness of socio-cognitive testing in NCDs in Europe. Methods: Stakeholders’ needs will be investigated on a country-based level through a survey distributed among members of European caregiver associations. A Delphi methodology will be applied to reach an expert consensus based on clinical needs. Primary outcomes will be the definition of: i) a set of European guidelines and clinical research priorities based on the Delphi procedure and bottom-up needs; ii) a set of stakeholders’ recommendations on a better use of socio-cognitive markers in NCD patients. Impact: Through a combined top-down (research experts) and bottom-up (clinicians & stakeholders) approach, this project will have both scientific and socio-economic impact. It will foster a methodological advancement in the field of NCDs by providing harmonised socio-cognitive protocols for European memory clinics. A consistent use over time of low-cost neuropsychological measures able to accurately capture information on socio-affective changes in patients may provide crucial information on social well-being of patients and their social network (families and caregivers). Thus, these new recommendations will provide not only a useful gateway for a better use of second-level biomarkers and possible outcomes for future clinical trials in NCDs, but also useful clinical information for detecting and monitoring progression of disorders of social behaviour and socio-affective domain for the ultimate benefit of the patient-caregiver dyad.