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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05306834 on ClinicalTrials.gov