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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age60-88
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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 ...)

Trial design

Treatments tested in this trial

  • blood pressure lowering algorithm
  • usual strategy

Treatment groups

820 Participants
are divided into 2 treatment groups