In recent years there is mounting evidence that type 2 diabetes (T2D) is associated with cognitive impairment and dementia, which can be considered as a “new” long-term diabetic co-morbid complication with dramatic consequences for patients and their families and a significant impact for healthcare systems. At present there are no reported phenotypic indicators or reliable tests to identify T2D patients at risk of developing dementia. Since the retina is ontogenically a brain-derived tissue, we propose that the evaluation of retinal parameters related to either neurodegeneration or microvascular disease will be robust and valuable biomarkers to identify those T2D patients at higher risk of developing cognitive impairment and dementia. On this basis the overarching aims of the project are: 1) To investigate the common mechanisms involved in the pathogenesis of DR and cognitive impairment in the T2D. 2) To use the retina as a tool to identifying individuals with T2D at a higher risk of developing cognitive decline or dementia. Our multidisciplinary consortium (RECOGNISED) consist of top research leaders in the field belonging to 15 prestigious institutions as well as EATRIS, IDF-Europe and Alzheimer Europe and 3 SMEs. RECOGNISED will apply innovative approaches to identify the molecular mechanisms involved in the high prevalence of cognitive impairment and dementia in T2D population and will use this knowledge to characterize clinical phenotypes (personalized medicine) based on retinal functional and structural characteristics and serum biomarkers in order to stratify the risk and severity of cognitive decline. Previously collected data from registries, cohorts and biobanks will be appropriately exploited and robust new data will be generated that will guide clinical recommendations and open up new therapeutic strategies. Ultimately, RECOGNISED project will help to reduce the huge societal and economic burden associated with diabetes-related cognitive impairment.

The ISIDORe consortium, made of the capacities of European ESFRI infrastructures and coordinated networks, proposes to assemble the largest and most diverse research and service providing instrument to study infectious diseases in Europe, from structural biology to clinical trials. Giving scientists access to the whole extent of our state of the art facilities, cutting edge services, advanced equipment and expertise, in an integrated way and with a common goal, will enable or accelerate the generation of new knowledge and intervention tools to ultimately help control SARS CoV 2 in particular, and epidemic prone pathogens in general, while avoiding fragmentation and duplication among European initiatives. Such a global and interdisciplinary approach is meant to allow the implementation of user projects that are larger, more ambitious and more impactful than the EU supported transnational activities that the consortium is used to run. Our proposition is ambitious but achievable in a timely fashion due to the relevance and previous experience of the partners that we have gathered and that have complementary fields of expertise, which addresses the need for an interdisciplinary effort. Leveraging all these existing strengths to develop synergies will create an additional value and enhance Europe capacity for controlling emerging or re emerging and epidemic infectious diseases, starting with the COVID 19 pandemic. Such a global and coordinated approach is consistent with the recommendations of the One Health concept and necessary to make significant contributions to solving complex societal problems like epidemics and pandemics.

Despite significant advances in the treatment and understanding of late stage age-related macular degeneration (AMD), it continues to be the main cause of irreversible severe visual loss in Europe and its prevalence and incidence will increase with current demographic trends. In order to reduce the significant burden of late stage AMD, novel interventions should aim at stopping or delaying progression from the preceding disease stage intermediate AMD (iAMD) to late stage AMD. As a prerequisite, validated clinical endpoints for iAMD are needed. These should be acceptable to regulatory agencies, health technology assessment (HTA) bodies, and payers. Currently such endpoints do not exist for iAMD clinical trials (CTs). In addition, there is good evidence indicating that patients with iAMD experience some impairment of visual function yet it is unknown to what extend this impacts the patients’ life nor can it be reliably measured and quantified. It is also unknown whether there are specific risk factors in the population of iAMD patients which identify those with more rapid progression to late stages of the disease. Therefore, to enable successful development of iAMD interventions validated functional, morphological and patient--reported endpoints for CTs, which are clinically meaningful and accepted by regulatory agencies, are required. In addition, functional decline in iAMD, as well as, specific risk factors for iAMD progression to late stage AMD need to be better characterized to inform and improve conduct of future iAMD CTs. Against this background, the major objective of MACUSTAR is to develop novel clinical endpoints for CTs with a regulatory and patient access intention in patients with iAMD. Additional objectives are to characterize visual impairment in iAMD and its progression, as well as, identify risk factors for progression. For clinical endpoint development, functional, structural and patient-reported outcome measures will be assessed with regards to