Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals "LEOPOLD"

Recruiting

Phase 4 Results N/A

Update History

2 Jul '16
The eligibility criteria were updated.
New
Inclusion Criteria: - 60 to 88 years old patients; - Patient with cognitive complaint with MMSE ≥ 20performed within 6 months prior to enrollment (with or without dementia) - Patient with a socio-educational level ≥ 3 - Presence of hyperintensities of moderate to high grade on the last MRI or old scan (grades C and D on the modified Scheltens scale, grades 2/3 Fazekas). - Hypertension defined by a Systolic Blood Pressure (SBP) and / or a Diastolic Blood Pressure (DBP) ≥ 140/90 mmHg, treated or not - Affiliation to a social security system Exclusion Criteria: - Presence of severe orthostatic hypotension defined as a decrease of 30 mmHg in SBP standing within 3 minutes - Contraindication to MRI (presence of ferromagnetic foreign body (especially some intracranial clips, some heart valves, intraocular foreign bodies, metal prosthesis), subject carrying pacemaker, claustrophobic participants) - Severe diseases associated with a life expectancy of less than 3 months; - Major physical impairments that can interfere with the feasibility of the tests (sight, hearing ...) - Presence of another dementia different than Alzheimer's disease vascular dementia or mixed dementia, - Persons under guardianship; - Secondary hypertension: renovascular hypertension, primary aldosteronism, pheochromocytoma ...; - Patient already receiving 4 or more antihypertensive drugs at maximum dosage - Patient participating in another clinical research study on drug requiring exclusion period - severe renal impairment
Old
Inclusion Criteria: - 60 to 85 years old patients; - Patient with cognitive complaint with MMSE ≥ 20 (with or without dementia) - Patient with a socio-educational level ≥ 3 - Presence of hyperintensities of moderate to high grade on the last MRI (under 5 years) (grades C and D on the modified Scheltens scale, grades 2/3 Fazekas). - Hypertension defined by a Systolic Blood Pressure (SBP) and / or a Diastolic Blood Pressure (DBP) ≥ 140/90 mmHg, treated or not - Absence of severe renal impairment - Affiliation to a social security system Exclusion Criteria: - Presence of severe orthostatic hypotension defined as a decrease of 30 mmHg in SBP standing within 3 minutes - Contraindication to MRI (presence of ferromagnetic foreign body (especially some intracranial clips, some heart valves, intraocular foreign bodies, metal prosthesis), subject carrying pacemaker, claustrophobic participants) - Severe diseases associated with a life expectancy of less than 3 months; - Major physical impairments that can interfere with the feasibility of the tests (sight, hearing ...) - Presence of another dementia different than Alzheimer's disease vascular dementia Lewy Body or mixed dementia, - Persons under guardianship; - Secondary hypertension: renovascular hypertension, primary aldosteronism, pheochromocytoma ...; - Patient already receiving 4 or more antihypertensive drugs - Patient participating in another clinical research study on drug requiring exclusion period
A location was updated in Paris.
New
The overall status was updated to "Recruiting" at Memory Resources Centre and South of Ile de France Search - Broca Hospital.