Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals (NCT02472028) | Clinical Trial Compass
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
France820 participantsStarted 2015-09
Plain-language summary
The purpose of the study is to test the hypothesis of slowing the progression of White Matter Lesions (WML) by lowering blood pressure (BP) in patients with cognitive complaints and a moderate to high grade of WML on brain MRI.
Who can participate
Age range60 Years – 88 Years
SexALL
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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
* Informed consent given, signed consent
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…
What they're measuring
1
The main criterion is based on the quantitative assessment of White Matter Lesions (WML) volumes at the beginning and at the end of the study for each patient and each arm of the trial. The WML volume from the final MRI is compared to that of the initial