Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease
NCT ID: NCT05306834
Last Updated: 2024-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2022-11-10
2027-11-30
Brief Summary
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Detailed Description
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This study aims to explore the relation of brain and retinal microvasculature image characteristics (imaging biomarkers), as well as molecular biomarkers derived from blood, with presence or absence of extensive cSVD and with cognitive and other clinical characteristics in two groups of 200 patients 60+ years of age. The first group will consist of patients with little or no white matter hyperintensities on brain MRI (no or minor MRI features of cSVD); while the second will include patients with moderate to severe white matter hyperintensities (MRI features of extensive cSVD).
This will create a unique deeply characterized resource for epidemiological and mechanistic investigations of cSVD, which can also serve as a pilot setting to test the trajectories and requirements for individualized patient care of cSVD patients.
The combination of retinal microvascular measurements using innovative multimodal imaging is entirely novel to our knowledge. In the context of the RHU SHIVA program, the same retained imaging protocol will be implemented for 400 young adults, which will provide insight into trajectories of these retinal biomarkers across the adult lifespan).
For the molecular biomarkers allow the validation of genomic, epigenomic, transcriptomic, proteomic, and metabolomic biomarkers for cSVD identified through secondary use of large existing cohort studies in the general population (3C, i-Share cohorts), in persons with memory complaints (MEMENTO cohort), and in collaboration with other cohorts with the Cohorts for Heart and Aging Research in Genomic Epidemiology (CHARGE) consortium, also as part of the RHU SHIVA program.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Minimal cSVD patient group
little or no white matter hyperintensities
Retinal Imaging
Auto-Refractometry / Adaptative Optics (OA) / Swept Source Optical Coherence Tomography (SS-OCT-A) / Globe Axial length measurements / Color Retinophotography of the retina.
Blood sample
Analyses of molecular biomarkers including
Evaluation of cardiovascular risks
Measurement of blood pressure and arterial stiffness
Brain imaging (MRI)
3DT1 / 3DFLAIR / T2GRE / DTI 15 directions (and B0MAP)
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)
Geriatric Depression Scale (GDS)
15 items
Instrumental Activities of Daily Living (IADL)
Instrumental Activities of Daily Living (IADL)
Unipodal standing test
Unipodal standing test
Walking speed measurement
over 5 meters
Extensive cSVD patient group
moderate to severe white matter hyperintensities
Retinal Imaging
Auto-Refractometry / Adaptative Optics (OA) / Swept Source Optical Coherence Tomography (SS-OCT-A) / Globe Axial length measurements / Color Retinophotography of the retina.
Blood sample
Analyses of molecular biomarkers including
Evaluation of cardiovascular risks
Measurement of blood pressure and arterial stiffness
Brain imaging (MRI)
3DT1 / 3DFLAIR / T2GRE / DTI 15 directions (and B0MAP)
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)
Geriatric Depression Scale (GDS)
15 items
Instrumental Activities of Daily Living (IADL)
Instrumental Activities of Daily Living (IADL)
Unipodal standing test
Unipodal standing test
Walking speed measurement
over 5 meters
Interventions
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Retinal Imaging
Auto-Refractometry / Adaptative Optics (OA) / Swept Source Optical Coherence Tomography (SS-OCT-A) / Globe Axial length measurements / Color Retinophotography of the retina.
Blood sample
Analyses of molecular biomarkers including
Evaluation of cardiovascular risks
Measurement of blood pressure and arterial stiffness
Brain imaging (MRI)
3DT1 / 3DFLAIR / T2GRE / DTI 15 directions (and B0MAP)
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)
Geriatric Depression Scale (GDS)
15 items
Instrumental Activities of Daily Living (IADL)
Instrumental Activities of Daily Living (IADL)
Unipodal standing test
Unipodal standing test
Walking speed measurement
over 5 meters
Eligibility Criteria
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Inclusion Criteria
1. 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).
2. 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
Exclusion Criteria
1. 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
2. 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),
* 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 dioptries
* Patients with known allergy to Tropicamide (Mydriaticum®)
* Patients with an extensive cataract
* Patients with ptosis
60 Years
88 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Olivier HANON, Pr
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Marc JOLIOT, Dr
Role: STUDY_CHAIR
Unité CNRS UMR5296, Groupe d'Imagerie
Cécile DELCOURT, Dr
Role: STUDY_CHAIR
Centre INSERM U1219 Bordeaux Population Health
Locations
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Bordeaux Hospital
Bordeaux, , France
Broca Hospital
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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DEBETTE Stéphanie, Pr
Role: primary
HANON Olivier, Pr
Role: primary
Other Identifiers
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CHUBX 2021/22
Identifier Type: -
Identifier Source: org_study_id
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