Principal Investigator:  Professor Noemi Lois                                               

Name of the Study:  Retinal and cognitive dysfunction in type 2 diabetes: unravelling the common pathways and identification of patients at risk of dementia.

RECOGNISED  -for short

Why is this Study important?

Type 2 diabetes is known to be an independent risk factor for developing cognitive impairment and dementia, with studies showing that people living with T2D have a two-fold higher risk of developing Alzheimer’s disease (AD) when compared to the general population. AD is a neurodegenerative disease that leads to the progressive loss of brain cells, which causes cognitive decline and, eventually, dementia. People with cognitive impairment are more prone to have impaired diabetes self-management, poor glycaemic control and an increased incidence of diabetes-related complications, which presents significant challenges both for individuals and healthcare systems on how best to manage diabetes care. Identifying people with cognitive problems is essential so that appropriate support can be given to them.

Given that the retina shares similar embryologic origin, anatomical features and physiological properties with the brain, it offers a unique and accessible “window” to study the correlates and consequences of subclinical pathology in patients with cognitive impairment. Our hypothesis is that the neurodegeneration of the retina will run in parallel to the neurodegeneration of the brain and, therefore, the signs of neurodysfunction in the retinal assessment will be more evident in those patients with rapid cognitive decline. Microangiopathy will also participate in cognitive decline and its specific role, as well as usefulness of retinal imaging, will be determined.

What is the Research question/aim?

The four-year long RECOGNISED project will study the biological mechanisms that cause structural and functional alterations in the retina in people with type 2 diabetes, to determine whether these same pathways play a role in the events observed in the brain during the development of cognitive impairment and dementia. Importantly, RECOGNISED will reveal whether evaluating the retina, easily accessible with current non-invasive technologies, could help in identifying earlier cognitive impairment in people with T2D, so that appropriate support can be given. RECOGNISED will also analyse previously-collected data and samples from registries, cohorts and biobanks. By gaining knowledge on the mechanisms of disease, RECOGNISED will help to identify new potential therapeutic interventions.

What the Study involves: 

The study consists of a cross-sectional part and a longitudinal part.

The cross-sectional study will allow characterization of a large group of individuals with T2D (up to 720 participants) and establish correlations between the various functional and structural retinal endpoints obtained and the presence/absence of mild cognitive impairment (MCI) and dementia. The cross-sectional study will allow identification of T2D patients with MCI; of these a group of 168 T2D patients with MCI and a group of 63 T2D patients without MCI, which will act as a control group, will be then followed prospectively in the longitudinal cohort study to evaluate end points predictive of cognitive decline and dementia.

PPI Involvement: 

The protocol and patient related materials were prepared by the consortium and with the input of the RECOGNISED Patient and Public Involvement Group, to ensure they are adequate and understandable. The project receives support from Alzheimer’s Europe and the International Diabetes Federation.

Who can take part in the Study? Patients with Type 2 Diabetes that have had diabetes for at least 5 years and who are 65 years of age or older.