Lowering blood pressure to slow brain lesions in older adults

LEukoaraiosis and blOod Pressure Reduction in OLD People

This study is testing if lowering blood pressure can help older adults with memory issues slow down the development of brain lesions.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 820 (estimated)
• Ages: 60 Years to 88 Years
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 2 sites (Bordeaux, Pellegrin Hospital Group and 1 other locations)
• Trial ID: NCT02472028 on ClinicalTrials.gov

What this trial studies

This study aims to determine if reducing blood pressure can slow the progression of White Matter Lesions (WML) in elderly patients experiencing cognitive complaints. It involves a prospective randomized open blinded endpoint design, where participants will be divided into two groups: one receiving an enhanced blood pressure management strategy and the other receiving usual care. The study will enroll 820 patients across multiple Memory Resources and Research Centers, with evaluations including MRI scans to assess changes in WML over time.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 60 to 88 with cognitive complaints and moderate to high-grade WML on MRI.

Not a fit: Patients with severe orthostatic hypotension or contraindications to MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could help prevent or slow cognitive decline in older adults with vascular brain lesions.

How similar studies have performed: While studies have explored blood pressure management in relation to cognitive health, this specific approach targeting WML progression is novel.

Eligibility criteria

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 requiring exclusion period
* severe renal impairment

Where this trial is running

Bordeaux, Pellegrin Hospital Group and 1 other locations

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

Study contacts

• Principal investigator: Olivier HANON, MD, PhD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Olivier HANON, MD, PhD

Conditions: Cerebrovascular Disorders, Stroke, Antihypertensive Agents, Arterial Pressure, Memory Disorders