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NCT02472028RecruitingPhase 4

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

LEukoaraiosis and blOod Pressure Reduction in OLD People

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
820 (estimated)
First submitted
27 Apr 2015
Start date
Sept 2015
Primary completion date
11 Sept 2028
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Diseases
Stroke
NCT number
NCT02472028

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 820
  • From Sept 2015 to the primary completion date, 11 Sept 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient already receiving 4 or more antihypertensive drugs at maximum dosage
  • Patient participating in another clinical research study on drug requiring exclusion period

Other illness

  • 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;
  • Presence of another dementia different than Alzheimer's disease vascular dementia or mixed dementia,
  • Secondary hypertension: renovascular hypertension, primary aldosteronism, pheochromocytoma ...;
  • severe renal impairment

Other

  • Presence of severe orthostatic hypotension defined as a decrease of 30 mmHg in SBP standing within 3 minutes
  • Major physical impairments that can interfere with the feasibility of the tests (sight, hearing ...)
  • Persons under guardianship;

Who the study is looking for

  • 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

Age in the registry: 60 years to 88 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memory for Research and Resources Center / Neuroscience pole
Coordinator of this site? Confirm its status
BordeauxFranceNot yet recruiting
Memory Resources Centre and South of Ile de France Search - Broca Hospital
Coordinator of this site? Confirm its status
ParisFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.