Workpackages - Objectives

Workpackage 1 - General Coordination and Management

To provide coordination and management activities that will ensure the integration and completion of the work project.

Workpackage 2 - Basic Research: Deciphering common molecular mechanisms leading to neurovascular pathology in Alzheimer’s brain and diabetic retina

1. To evaluate shared pathophysiology in Alzheimer’s brain and diabetic retina.

2. To identify common pathogenic pathways relating to the neurovascular unit in Alzheimer’s brain and diabetic retina.

3. To establish key molecular mechanisms and novel therapeutic targets to prevent neurovascular pathology in Alzheimer’s brain and diabetic retina.

Workpackage 3 - Prospective multicentric, cross-sectional and cohort clinical study

To develop and conduct the RECOGNISED clinical study, with a total duration of 36 months comprising 6 months of recruitment and 30 months of follow-up. It will be designed, coordinated, managed, monitored and executed according to current international laws and regulations and in compliance with regulatory requirements in all participating countries, the General Data Protection Regulation and Good Clinical Practice Guidelines (ICH-GCP). It will be ensured that the clinical study subjects` safety, well-being and rights are protected and investigators comply with the approved protocols.

Workpackage 4 - Central Reading and Imaging Processing

1. To develop standard operating procedures (SOPs) for exams acquisition (ophthalmological and brain examinations) and certification of clinical sites.

2. To develop study materials for each Central Reading Centre (CRC) analysis (ophthalmological and brain examinations) and training,

3. To perform centralized analysis of ophthalmological (AIBILI-CORC) and brain (VHIR and UMC) examinations.

Workpackage 5 - Neuropsychological and quality of life evaluation

1. To validate the screenings tools (SAGE and MoCA) in T2D patients to identify cognitive impairment.

2. To assess the influence of depression and quality of life on the results of tests aimed at assessing the cognitive status in T2D patients.

3. To establish the influence of sex on neuropsychological test results and quality of life in T2D patients.

4. To explore cognitive profiles in relation to T2D patients.

5. To validate the Diabetes-Specific Dementia Risk Score (DSDRS) for the diagnosis of MCI.

6. To identify a simple and reliable neuropsychological test battery (NTB) for the identification of cognitive impairment in T2D patients.

Workpackage 6 - Circulating Biomarkers

1.To identify circulating biomarkers associated with high risk progression of cognitive decline in T2D patients.

2. To determine the relationship between serum biomarkers and the findings observed in retina and brain examinations, as well as the progression rate of cognitive decline.

Workpackage 7 - Data Mining and System Biology

1.To identify mechanistic links between DR and AD by analysing model data by systems biology approaches.

2. To identify predictive biomarkers of cognitive decline in T2D population by integrating and analysing all patient data.

Workpackage 8 - Dissemination and Exploitation

1. To ensure that the “plan for the dissemination and exploitation of the project results” is a fully functioning document which is proactively revised and updated as required.

2. To disseminate the results and target-oriented key messages to relevant stakeholders by means of appropriate channels with the final aim of promoting RECOGNISED visibility.

3. To pave the way for a full exploitation of the results generated by the consortium beyond the project duration.

Workpackage 9 - Communication Activities

1. To ensure the impact of the RECOGNISED project on the different stakeholders and the general public by using pertinent communication messages.

2. To develop a target-oriented plan for use of the appropriate communication channels in a strategic and effective manner.

Workpackage 10 - Ethics requirements

To ensure compliance with the 'ethics requirements' set out in this work package.

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