Actively Recruiting
LEukoaraiosis and blOod Pressure Reduction in OLD People
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-05
820
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether lowering blood pressure can slow the progression of White Matter Lesions (WML) in older adults who have cognitive complaints and moderate to high levels of these brain abnormalities seen on MRI. WML are linked to a higher risk of dementia, especially Alzheimer's disease, and high blood pressure is a major risk factor for developing these lesions. This study tests if enhanced blood pressure control can reduce WML progression compared to usual care. Participants will be randomly assigned to one of two groups: an enhanced strategy group aiming to lower systolic blood pressure to below 135 mmHg using antihypertensive medications following national and international guidelines, or a usual care group receiving standard blood pressure management. The choice of specific drugs is left to the investigators. The study includes an initial MRI at the start and a follow-up MRI after about 36 months to assess brain changes. During the study, participants will undergo yearly neuropsychological tests, walking speed and balance assessments, repeated blood pressure measurements, and monitoring for neurological symptoms. Blood tests will be done at baseline, and MRI scans will confirm eligibility and measure lesion volume changes. The main outcome is the change in WML volume after approximately three years. Other outcomes include brain volume changes, cognitive performance, incidence of dementia and vascular events, and mortality. Total participation lasts about 3.5 years, with close monitoring throughout.
CONDITIONS
Brief Title
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 60 and 88 years
- Cognitive complaints with MMSE score 20 or higher within 6 months before enrollment
- Socio-educational level of 3 or higher
- Moderate to high grade White Matter Lesions on recent MRI or scan (grades C and D on modified Scheltens scale, grades 2/3 Fazekas)
- Hypertension defined as systolic and/or diastolic blood pressure 140/90 mmHg or higher, treated or untreated
- Affiliation to a social security system
- Signed informed consent
You will not qualify if you...
- Severe orthostatic hypotension with a decrease of 30 mmHg in systolic blood pressure upon standing within 3 minutes
- Contraindications to MRI such as ferromagnetic foreign bodies, pacemaker, or claustrophobia
- Severe diseases with life expectancy less than 3 months
- Major physical impairments affecting feasibility of tests (e.g., sight, hearing)
- Dementia types other than Alzheimer's, vascular, or mixed dementia
- Persons under legal guardianship
- Secondary hypertension causes like renovascular hypertension, primary aldosteronism, pheochromocytoma
- Current use of four or more antihypertensive drugs at maximum doses
- Participation in another drug clinical trial requiring exclusion period
- Severe renal impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 months
Participants receive either an enhanced blood pressure lowering strategy aiming to reduce systolic blood pressure to less than 135 mmHg, or usual blood pressure care as part of routine healthcare.
Yearly visits for clinical and neuropsychological evaluations with repeated blood pressure measurements
Duration - Up to 6 months after treatment
Participants continue to be monitored for changes in brain imaging, neuropsychological tests, walking speed, and incident vascular events after treatment ends.
1 to 2 visits depending on assessments required
Trial Site Locations
Total: 2 locations
1
Memory for Research and Resources Center / Neuroscience pole
Bordeaux, Pellegrin Hospital Group, France, 33076
Not Yet Recruiting
2
Memory Resources Centre and South of Ile de France Search - Broca Hospital
Paris, France, 75013
Actively Recruiting
Research Team
O
Olivier HANON, MD, PhD
C
Christophe TZOURIO, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here