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

Recruiting now · Not applicable

Conditions studied: Cerebral Small Vessel Diseases, Stroke, Dementia

In brief

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.

Key facts

Study ID

NCT05306834

Run by

University Hospital, Bordeaux

People needed

400

Starts

2022-11-10

Expected to finish

2027-11-01

Last updated by the study team

2024-01-26

Who can join

Age: 60 and older, up to 88. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For the extensive cSVD patient group
• For the extensive cSVD patient group included in the LEOPOLD trial:
• 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).
• For the extensive cSVD patient group not included in the LEOPOLD trial:
• Patients aged 60 to 88 years,
• Patients with a cognitive complaint MMSE ≥ 20 performed in the 6 months before inclusion, associated or not with impaired cognitive tests and/or diaognosis of incipient dementia without pronounced cognitive deterioration,
• Patients with a socio-educational level ≥ 3,
• Patients with a moderate to high grade of hypersignals on an MRI OR on an CT scan performed prior inclusion (grades C and D of the modified Scheltens scale or grade 2/3 Fazekas),
• Arterial hypertension defined by a Systolic Blood Pressure (SBP) and / or Diastolic Blood Pressure (DBP) ≥ 140/90 mmHg (according to the definition of the national health authority [HAS]), treated or not, confirmed within the previous 12 months or at the latest on the day of inclusion.
• 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)
• For the minimal cSVD patient group:
• Patients aged 60 to 88 years,
• Patients with a cognitive complaint (MMSE ≥ 20 performed at the SHIVA inclusion visit or in the 6 monts prior the visit) associated or not with impaired cognitive tests and/or diagnosis of incipient dementia without pronounced cognitive deterioration,
• Patients with little or no white matter hypertensities on brain MRI (grades 0 or 1 on the Fazekas scale); without lacunes or microbleeds,
• Arterial hypertension defined by a Systolic Blood Pressure (SBP) and / or Diastolic Blood Pressure (DBP) ≥ 140/90 mmHg (according to the definition of the national health authority [HAS]), treated or not, confirmed within the previous 12 months or at the latest on the day of inclusion. Blood pressure values for this inclusion criterion can be objectified by several self-measurements performed by the patient at home for 3 days in a sitting or lying position (3 measurements on sitting or lying position and 3 measurements in standing position).
• 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

You may not qualify if…

• For Extensive cSVD patient group :
• For the extensive cSVD patient group also included in the LEOPOLD trial:
• patients with severe myopia greater than -6 dioptres
• partients with known allergy to Tropicamide (Mydriaticum®)
• patients with an extensive cataract
• patients with ptosis
• For the extensive cSVD patient group not included in the LEOPOLD trial:
• Orthostatic hypotension defined by a decrease of 20 mmHg in SBP and / or 10 mmHg in DBP in a standing position at 3 minutes sought in the previous 3 months or on the day of inclusion,
• Very severe renal impairment (creatinine clearance less than 15 ml / min) on a blood test dating back less than one year,
• Secondary hypertension: renovascular hypertension, primary hyperaldosteronism, pheochromocytoma...
• Contraindication to MRI (presence of a ferromagnetic foreign body, in particular certain intracranial clips, certain heart valves, an intraocular foreign body, metal prosthesis, subject carrying a pacemaker, subject carrying prosthetic heart valves incompatible with MRI. ventricular shunt, claustrophobia),
• Associated severe diseases, with a life expectancy of less than 3 months,
• Physical problems likely to interfere with the feasibility of the tests (sight, hearing, etc.),
• Existence of dementia of which the etiology is distinct from Alzheimer's disease, vascular or mixed dementia
• Persons under tutorship or curatorship,
• Patients with loss of autonomy living in EHPAD (nursing home)
• patients with severe myopia greater than -6 dioptres
• participants with known allergy to Tropicamide (Mydriaticum®)
• patients with an extensive cataract
• patients with ptosis
• For the minimal cSVD patient group:
• Orthostatic hypotension defined by a decrease of 20 mmHg in SBP and / or 10 mmHg in DBP in a standing position at 3 minutes sought in the previous 3 months or on the day of inclusion,
• Very severe renal impairment (creatinine clearance less than 15 ml / min) on a blood test dating back less than one year,
• Secondary hypertension: renovascular hypertension, primary hyperaldosteronism, pheochromocytoma...
• Contraindication to MRI (presence of a ferromagnetic foreign body, in particular certain intracranial clips, certain heart valves, an intraocular foreign body, metal prosthesis, subject carrying a pacemaker, subject carrying prosthetic heart valves incompatible with MRI. ventricular shunt, claustrophobia),

Where it is running

• Bordeaux Hospital — Bordeaux, France (enrolling)
• Broca Hospital — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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