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.
ID
Source
Brief title
Condition
- Other condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Health condition
cognitieve toestand
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Retinal sensitivity assessed by microperimetry
Secondary outcome
a. Retinal variables:
- Retinal neurodysfunction/ neurodegeneration assessed by gaze fixation
(microperimetry), Full-field photopic electriretinogram (ERG) and Spectral
Domain Optical Coherence Tomography (SDOCT).
- Vascular abnormalities assessed by Optical Coherence Tomography Angiography
(OCT-A), and Ultra-wide field Fundus Fluorescein Angiography (FFA).
b. Brain imaging assessed by Magnetic Resonance Imaging (MRI) and 18
Fluoro-2-deoxyglucose-Positron Emission Tomography (18FDG-PET).
c. Circulating biomarkers
d. Other: Geriatric Depression Scale (GDS-15), EQ-5D-3L questionnaire, 25-item
National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) and
Diabetes Specific Dementia Risk Score (DSDRS).
Background 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.
Study objective
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.
Study design
It is a multinational and multicentre prospective, longitudinal cohort
observational study.
Study burden and risks
Disadvantages of participating in the study may be
- possible discomfort during the blood test in the studie
- spending more time
- extra hospital visits
- additional tests
Benefit of participating in the study may be
- more testing and research. These can pinpoint any issues that would otherwise
have gone unnoticed to more advanced stages.
Passeig Vall dHebron, Edificio De Recerca 119-129
Barcelona 08035
ES
Passeig Vall dHebron, Edificio De Recerca 119-129
Barcelona 08035
ES
Listed location countries
Age
Inclusion criteria
1. Diagnosis of mild to moderate nonproliferative diabetic retinopathy (ETDRS
DR level 20
to 47) confirmed by the reading centre or with no overt retinopathy.
2. Diagnosis of MCI confirmed by a neuropsychological test battery (NTB), CDR
and a specialized physician or a neuropsychologist. For the control group the
absence of MCI will also be confirmed by a NTB and a specialized physician or a
neuropsychologist.
Exclusion criteria
1. Major depression (GDS-15 = 9)
2. Established dementia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04281186 |
| CCMO | NL74434.018.20 |