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

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

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

Treatments tested in this trial

  • Retinal Imaging
  • Blood sample
  • Evaluation of cardiovascular risks
  • Brain imaging (MRI)
  • Cognitive Tests
  • Geriatric Depression Scale (GDS)
  • Instrumental Activities of Daily Living (IADL)
  • Unipodal standing test
  • Walking speed measurement

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators