Last updated: January 25, 2024
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting
Phase
N/A
Condition
Dementia
Mental Disability
Cerebral Ischemia
Treatment
Unipodal standing test
Blood sample
Cognitive Tests
Clinical Study ID
NCT05306834
CHUBX 2021/22
Ages 60-88 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: 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 onSIEMENS 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 theresearch 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 beforeinclusion, associated or not with impaired cognitive tests and/or diaognosis ofincipient 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 scanperformed prior inclusion (grades C and D of the modified Scheltens scale orgrade 2/3 Fazekas),
- Arterial hypertension defined by a Systolic Blood Pressure (SBP) and / orDiastolic Blood Pressure (DBP) ≥ 140/90 mmHg (according to the definition of thenational 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 theresearch 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 visitor in the 6 monts prior the visit) associated or not with impaired cognitive testsand/or diagnosis of incipient dementia without pronounced cognitive deterioration,
- Patients with little or no white matter hypertensities on brain MRI (grades 0 or 1 onthe Fazekas scale); without lacunes or microbleeds,
- Arterial hypertension defined by a Systolic Blood Pressure (SBP) and / or DiastolicBlood Pressure (DBP) ≥ 140/90 mmHg (according to the definition of the national healthauthority [HAS]), treated or not, confirmed within the previous 12 months or at thelatest on the day of inclusion. Blood pressure values for this inclusion criterion canbe objectified by several self-measurements performed by the patient at home for 3days in a sitting or lying position (3 measurements on sitting or lying position and 3measurements in standing position).
- Being affiliated or beneficiary of the French national health insurance ("sécuritésociale"),
- Free, informed and written consent signed by the participant and the investigator (atthe latest on the day of inclusion and before any examination required by the researchstudy
Exclusion
Exclusion Criteria: 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 mmHgin DBP in a standing position at 3 minutes sought in the previous 3 months or onthe day of inclusion,
- Very severe renal impairment (creatinine clearance less than 15 ml / min) on ablood test dating back less than one year,
- Secondary hypertension: renovascular hypertension, primary hyperaldosteronism,pheochromocytoma...
- Contraindication to MRI (presence of a ferromagnetic foreign body, in particularcertain intracranial clips, certain heart valves, an intraocular foreign body,metal prosthesis, subject carrying a pacemaker, subject carrying prosthetic heartvalves 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 inDBP in a standing position at 3 minutes sought in the previous 3 months or on the dayof inclusion,
- Very severe renal impairment (creatinine clearance less than 15 ml / min) on a bloodtest dating back less than one year,
- Secondary hypertension: renovascular hypertension, primary hyperaldosteronism,pheochromocytoma...
- Contraindication to MRI (presence of a ferromagnetic foreign body, in particularcertain intracranial clips, certain heart valves, an intraocular foreign body, metalprosthesis, subject carrying a pacemaker, subject carrying prosthetic heart valvesincompatible 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
Study Design
Total Participants: 400
Treatment Group(s): 9
Primary Treatment: Unipodal standing test
Phase:
Study Start date:
November 10, 2022
Estimated Completion Date:
November 30, 2027
Study Description
Connect with a study center
Bordeaux Hospital
Bordeaux, 33000
FranceActive - Recruiting
Broca Hospital
Paris, 75014
FranceActive - Recruiting

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