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

Cerebrovascular Disorders Clinical Trial

Official title: LEukoaraiosis and blOod Pressure Reduction in OLD People

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

SCIENTIFIC BACKGROUND: White Matter Lesions (WML) are cerebrovascular abnormalities discovered on MRI that are associated with an increased risk of dementia. High blood pressure (BP) is a major risk factor for WML. WML are therefore key lesions in the causal chain linking vascular factors and dementia, particularly Alzheimer's disease.

However, it has not been shown that lowering BP could limit the progression of the WML in people with cognitive impairment.

OBJECTIVES: To test the hypothesis of slowing progression of WML by lowering BP in patients with memory complaints with a moderate to high grade of WML on brain MRI.

STUDY DESIGN: PROBE (Prospective randomized open blinded end-point) trial. Blind reading of both MRI for every patient in each group. After stratified randomization on age, sex and center, patients will be assigned to two strategies:

• Reinforced Group (RG): enhanced strategy aiming at a systolic BP <135 mmHg;

• Usual Group (UG): usual strategy based on the usual routine care.

SAMPLE SIZE: patients will be enrolled (410 in each arm) in 12 Memory Resources and Research Center (CMRR) with access to 1.5 T or more MRI.

CONDUCT OF THE STUDY:

Duration of the inclusion period: 96 months and 2 weeks. Patient participation duration: 36 months + 6 months max Total study duration: 11 years. Clinical and para-clinical evaluation: MRI as part of research at the beginning of the study and before the end of the study at 36 months + 6 months max (primary endpoint); Clinical evaluation of neuropsychological tests at the beginning of the study and yearly ; walking speed measurement single leg stance balance test ; repeated BP measurements; monitoring of neurological signs and symptoms; blood test at the beginning of the study (electrolytes, lipid profiles, fasting blood glucose, if not existing); MRI if not existing for validation of the inclusion criterion and performed in the ordinary course. ;

Related Conditions & MeSH terms

• Cerebrovascular Disorders

• NCT number: NCT02472028
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Olivier HANON, MD, PhD
• Phone: 33 1 44 08 35 02
• Email: olivier.hanon@brc.aphp.fr
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2015
• Completion date: September 11, 2028