Health TrialsbyHealthPanel

Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease

ConditionsCerebral Small Vessel DiseasesStrokeDementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-88
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 60 to 88 years,

Patients included in the LEOPOLD trial and having performed their brain MRI on SIEMENS PRISMA machine

Being affiliated or beneficiary of the French national health insurance ("sécurité sociale"),

Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research study).

Disqualifiers

patients with severe myopia greater than -6 dioptres

partients with known allergy to Tropicamide (Mydriaticum®)

patients with an extensive cataract

patients with ptosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Retinal Imaging

    Procedure/Surgery

    Auto-Refractometry / Adaptative Optics (OA) / Swept Source Optical Coherence Tomography (SS-OCT-A) / Globe Axial length measurements / Color Retinophotography of the retina.

  • Blood sample

    Genetic

    Analyses of molecular biomarkers including

  • Evaluation of cardiovascular risks

    Procedure/Surgery

    Measurement of blood pressure and arterial stiffness

  • Brain imaging (MRI)

    Procedure/Surgery

    3DT1 / 3DFLAIR / T2GRE / DTI 15 directions (and B0MAP)

  • Cognitive Tests

    Other intervention

    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)

  • Geriatric Depression Scale (GDS)

    Other intervention

    15 items

  • Instrumental Activities of Daily Living (IADL)

    Other intervention

    Instrumental Activities of Daily Living (IADL)

  • Unipodal standing test

    Diagnostic test

    Unipodal standing test

  • Walking speed measurement

    Other intervention

    over 5 meters

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Minimal cSVD patient groupActive comparator 9 interventions
Group B: Extensive cSVD patient groupActive comparator 9 interventions

Trial outcomes

Primary outcomes

1

Comparison of images and the molecular data

This comparison should help identify relevant biomarkers to characterize and categorize cSVD. We will also more broadly look at the association of retinal microvascular markers and molecular biomarkers with all available MRI-markers of cSVD (beyond the presence or absence of extensive white matter hyperintensities that defines the cases and controls).

Time frame
Day 0 and Year 3

Secondary outcomes

1

Degree of association between retinal and brain marker

Degree of association between retinal and brain marker

Time frame
Day 0, Year 1 and Year 3
2

Degree of association between brain, microvascular and retinal marker

Data relating to cardiovascular risk factors / clinic data / the results of the cognitive tests, /the results of pan-genomic genotypes obtained by pan-genome genotyping or sequencing (and from blood samples) and other molecular markers

Time frame
Day 0, Year 1, Year 2 and Year 3
3

Correlation between retinal micovascular biomarkers

SS-OCT-A (swept source optical coherence tomography angiography) and OA(Adaptive Optic)

Time frame
Day 0, Year 1, Year 2 and Year 3
4

Reproducibility and time course of retinal vascular biomarkers

SS-OCT-A (swept source optical coherence tomography angiography) and OA (Adaptive Optic)

Time frame
Between Day 0 and Year 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bordeaux

Lead sponsor

Source ClinicalTrials.gov
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