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

Recruiting now · Phase 4

Conditions studied: Cerebrovascular Disorders

In brief

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.

Key facts

Study ID: NCT02472028
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 820
Starts: 2015-09-01
Expected to finish: 2028-09-11
Last updated by the study team: 2025-09-05

Who can join

Age: 60 and older, up to 88. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Memory Resources Centre and South of Ile de France Search - Broca Hospital — Paris, France (enrolling)
Memory for Research and Resources Center / Neuroscience pole — Bordeaux, Pellegrin Hospital Group, France

Full record on ClinicalTrials.gov

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