Retinal and Cognitive Dysfunction in Type 2 Diabetes — RECOGNISED  

Cognitive Dysfunction Clinical Trial

Official title: Retinal and Cognitive Dysfunction in Type 2 Diabetes: Unraveling the Common Pathways and Identification of Patients at Risk of Dementia

Status Active, not recruiting

Clinical Trial Summary

The retina shares similar embryologic origin, anatomical features and physiological properties with the brain and hence 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 also examined.

This is a multinational and multicentre cross-sectional study and prospective, longitudinal cohort observational study.

Clinical Trial Description

The study consists of two main parts: a cross-sectional part and a longitudinal part, aimed at a) to determine whether functional and/or structural retinal biomarkers or circulating biomarkers are able to differentiate people with mild cognitive impairment (MCI) within the type 2 diabetes (T2D) population (the investigators will be able to do in the cross-sectional study, and, thus, use retina and/or blood biomarkers as a potential proxy to events taking place in the brain); b)to determine whether functional and/or structural retinal biomarkers or circulating biomarkers can be used to determine the speed of cognitive decline in people with T2D and MCI and those at higher risk of developing dementia.

The cross-sectional study will allow characterization of a large group of individuals with T2D (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 T2D patients without MCI (n=63), 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.

The primary objective is: to assess whether retinal sensitivity measured by microperimetry is able to predict cognitive decline and progression to dementia in MCI T2D patients.

The secondary objectives are:

1. To assess whether retinal sensitivity, measured by microperimetry, can identify individuals with MCI among people with T2D.

2. To assess whether eye fixation, measured by microperimetry, can identify individuals with MCI among people with T2D.

3. To assess whether eye fixation measured by microperimetry is able to predict rapid cognitive decline in T2D patients with MCI.

4. To define a T2D phenotype at high risk of developing dementia based on retinal imaging and functional retinal assessments.

5. To determine whether retinal imaging and functional retinal assessments may identify individuals with MCI among people with T2D.

6. To define a T2D phenotype at high risk to develop cognitive decline and dementia based on retinal imaging plus brain imaging.

7. To define a T2D phenotype at high risk to develop dementia based on retinal imaging plus brain imaging plus circulating biomarkers.

8. To establish a score to predict cognitive decline or progression from MCI to dementia based on the variables included in the study. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Microperimetry
• Retinal Function

• NCT number: NCT04281186
• Study type: Observational
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Status: Active, not recruiting
• Start date: November 16, 2020
• Completion date: December 2023