Actively Recruiting
Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease
Led by University Hospital, Bordeaux · Updated on 2024-01-26
400
Participants Needed
2
Research Sites
259 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 60 and 88 years
- Affiliated or beneficiary of the French national health insurance
- Signed free, informed, and written consent before any study examination
- For extensive cSVD group included in LEOPOLD trial: brain MRI performed on SIEMENS PRISMA machine
- For extensive cSVD group not in LEOPOLD trial: cognitive complaint with MMSE score ≥ 20 within 6 months before inclusion, socio-educational level ≥ 3, moderate to high grade hypersignals on MRI or CT scan, arterial hypertension with SBP and/or DBP ≥ 140/90 mmHg confirmed within 12 months
- For minimal cSVD group: cognitive complaint with MMSE score ≥ 20 at SHIVA inclusion visit or within 6 months prior, little or no white matter hyperintensities on MRI (Fazekas grades 0 or 1), no lacunes or microbleeds, arterial hypertension with SBP and/or DBP ≥ 140/90 mmHg confirmed within 12 months by multiple home measurements
You will not qualify if you...
- Severe myopia greater than -6 diopters
- Known allergy to Tropicamide (Mydriaticum�)
- Extensive cataract
- Ptosis
- Orthostatic hypotension defined by decrease of 20 mmHg in SBP and/or 10 mmHg in DBP within 3 minutes standing in past 3 months or on day of inclusion
- Very severe renal impairment (creatinine clearance < 15 ml/min) on blood test less than one year old
- Secondary hypertension including renovascular hypertension, primary hyperaldosteronism, or pheochromocytoma
- Contraindication to MRI (presence of ferromagnetic foreign body, certain intracranial clips, heart valves, intraocular foreign body, metal prosthesis, pacemaker, incompatible prosthetic heart valves, ventricular shunt, claustrophobia)
- Severe diseases with life expectancy less than 3 months
- Physical problems interfering with tests (vision, hearing)
- Dementia with etiology distinct from Alzheimer's, vascular or mixed dementia
- Persons under tutorship or curatorship
- Patients with loss of autonomy living in nursing home (EHPAD)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Bordeaux Hospital
Bordeaux, France, 33000
Actively Recruiting
2
Broca Hospital
Paris, France, 75014
Actively Recruiting
Research Team
S
Stéphanie DEBETTE, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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