RecruitingPhase 4NCT02472028

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

LEukoaraiosis and blOod Pressure Reduction in OLD People


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

820 participants

Start Date

Sep 1, 2015

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 60 YearsMax Age: 88 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether lowering blood pressure in older adults can slow the growth of white matter lesions in the brain — areas of damage visible on brain MRI that are associated with cognitive decline and dementia. The study targets people with hypertension and visible brain changes who also have memory concerns. You may be eligible if: - You are between 60 and 88 years old - You have cognitive concerns or mild cognitive impairment (MMSE score ≥ 20) - You have moderate-to-severe white matter lesions seen on brain MRI - You have high blood pressure (≥ 140/90 mmHg), treated or untreated - You have a reasonable level of education and social support You may NOT be eligible if: - You have severe low blood pressure when standing (orthostatic hypotension) - You are unable to have an MRI (e.g., pacemaker, metal implants, claustrophobia) - You have a serious illness with life expectancy under 3 months - You have a dementia type other than Alzheimer's, vascular, or mixed dementia - You are already on 4 or more blood pressure medications at maximum dose - You have severe kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERblood pressure lowering algorithm

The treatments used in the "enhanced strategy" arm are those proposed by national (HAS2013, SFHTA2013) and international (ESH 2013) recommendations, according to their Marketing Authorization and Summary of Product Characteristics : Diuretics, beta-blockers, Angiotensin Converting Enzyme inhibitors, Angiotensin Receptor Blockers, Calcium Channel Blockers Throughout the study, choice of drugs in each therapeutic class is left on the investigator's initiative. All drugs of these classes may be used , no specific drug is tested in this study.

OTHERusual strategy

The implementation of antihypertensive therapy the current recommendations to reach the blood pressure target in usual care. Throughout the study, choice of drugs in each therapeutic class is left on the investigator's initiative. Combinations of different pharmacological classes can be tested in order to find the most effective and best tolerated combinations.


Locations(2)

Memory for Research and Resources Center / Neuroscience pole

Bordeaux, Pellegrin Hospital Group, France

Memory Resources Centre and South of Ile de France Search - Broca Hospital

Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT02472028


Related Trials