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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: LEukoaraiosis and blOod Pressure Reduction in OLD People

Brief 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.

Detailed Summary:

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: 820 patients will be enrolled (410 in each arm) in 25 Memory Resources and Research Center (CMRR) with access to 1.5 T or more MRI.

CONDUCT OF THE STUDY:

Duration of the inclusion period: 23 months and 2 weeks. Patient participation duration: 36 months +/- 2 weeks Total study duration: 5 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 (primary endpoint); Clinical evaluation of neuropsychological tests at the b
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: The main criterion is based on the quantitative assessment of White Matter Lesions (WML) volumes at the beginning and at the end of the study for each patient and each arm of the trial. The WML volume from the final MRI is compared to that of the initial [ Time Frame: 36 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Imaging criteria : changes in the number of large or confluent WML [ Time Frame: 36 months ]
  • Imaging criteria : changes in the volume of WML depending on their location (periventricular and deep white matter) [ Time Frame: 36 months ]
  • Imaging criteria : changes in the number of silent infarctus [ Time Frame: 36 months ]
  • Imaging criteria : changes in the number of microbleeds [ Time Frame: 36 months ]
  • Imaging criteria : evolution of brain volumes (gray matter, white matter, CSF, and regional volumes including hippocampus) [ Time Frame: 36 months ]
  • Clinical criteria: clinical criteria (changes in neuropsychological tests [ Time Frame: 36 months ]
  • Clinical criteria: changes inwalking speed [ Time Frame: 36 months ]
  • Clinical criteria: number of incident cases of dementia [ Time Frame: 36 months ]
  • Number of incident cases of vascular events validated by an expert committee [ Time Frame: 36 months ]
  • Clinical criteria: total mortality by cause [ Time Frame: 36 months ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: April 27, 2015
Date Started: September 2015
Date Completion: January 2019
Last Updated: June 30, 2016
Last Verified: June 2016