Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease
NCT05306834 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2024-01-26
Summary
Cerebral small Vessel Disease (cSVD), characterized by an alteration of the structure and function of small penetrating brain arteries, is highly prevalent in older persons from the general population and represents a leading cause of stroke and a major contributor to cognitive decline and dementia risk. In France \>4 million persons aged 60+ are estimated to have moderate to extensive covert cSVD (ccSVD), i.e. features of SVD on brain imaging without a history of clinical stroke. Better detection and management of covert cSVD would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. However, there are no specific mechanistic treatments for cSVD and hardly any recommendations worldwide on how to prevent and treat cSVD and related cognitive impairment. The aim of the present study, through the identification of novel cutting-edge multimodal biomarkers, is to develop innovative diagnostic and risk prediction tools for cSVD and its complications and to contribute to accelerating the discovery of novel drug targets and therapeutics strategies for cSVD.
Conditions
Interventions
- PROCEDURE
-
Retinal Imaging
Auto-Refractometry / Adaptative Optics (OA) / Swept Source Optical Coherence Tomography (SS-OCT-A) / Globe Axial length measurements / Color Retinophotography of the retina.
- GENETIC
-
Blood sample
Analyses of molecular biomarkers including
- PROCEDURE
-
Evaluation of cardiovascular risks
Measurement of blood pressure and arterial stiffness
- PROCEDURE
-
Brain imaging (MRI)
3DT1 / 3DFLAIR / T2GRE / DTI 15 directions (and B0MAP)
- OTHER
-
Cognitive Tests
Mini Mental State Examination (MMSE) / Montreal Cognitive Assessment (MoCA) / 16 items Free and Cued Recall (RL/RI 16 items) / Trail Making Test A et B (TMT A et B) / Frontal Assessment Battery (FAB) / Phonemic (letter P) and semantic (animals) verbal fluency tests / Digit Symbol Substitution Test (DSST)
- OTHER
-
Geriatric Depression Scale (GDS)
15 items
- OTHER
-
Instrumental Activities of Daily Living (IADL)
Instrumental Activities of Daily Living (IADL)
- DIAGNOSTIC_TEST
-
Unipodal standing test
Unipodal standing test
- OTHER
-
Walking speed measurement
over 5 meters
Sponsors & Collaborators
-
University Hospital, Bordeaux
lead OTHER
Principal Investigators
-
Olivier HANON, Pr · Assistance Publique - Hôpitaux de Paris
-
Marc JOLIOT, Dr · Unité CNRS UMR5296, Groupe d'Imagerie
-
Cécile DELCOURT, Dr · Centre INSERM U1219 Bordeaux Population Health
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 88 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-10
- Primary Completion
- 2027-11-30
- Completion
- 2027-11-30
Countries
- France
Study Locations
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