Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
LEOPOLD
LEukoaraiosis and blOod Pressure Reduction in OLD People
2 other identifiers
interventional
820
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2015
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 11, 2028
September 5, 2025
September 1, 2025
13 years
April 27, 2015
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
36 months + 6 months max
Secondary Outcomes (10)
Imaging criteria : changes in the number of large or confluent WML
36 months+ 6 months max
Imaging criteria : changes in the volume of WML depending on their location (periventricular and deep white matter)
36 months+ 6 months max
Imaging criteria : changes in the number of silent infarctus
36 months+ 6 months max
Imaging criteria : changes in the number of microbleeds
36 months+ 6 months max
Imaging criteria : evolution of brain volumes (gray matter, white matter, CSF, and regional volumes including hippocampus)
36 months+ 6 months max
- +5 more secondary outcomes
Study Arms (2)
blood pressure lowering algorithm
EXPERIMENTALenhanced strategy aiming to reduce systolic blood pressure to \<135 mmHg
usual strategy
ACTIVE COMPARATORusual strategy based on the usual care of routine care
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- severe renal impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memory for Research and Resources Center / Neuroscience pole
Bordeaux, Pellegrin Hospital Group, 33076, France
Memory Resources Centre and South of Ile de France Search - Broca Hospital
Paris, 75013, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christophe TZOURIO, MD, PhD
Inserm U897 - Bordeaux University
- PRINCIPAL INVESTIGATOR
Olivier HANON, MD, PhD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2015
First Posted
June 15, 2015
Study Start
September 1, 2015
Primary Completion (Estimated)
September 11, 2028
Study Completion (Estimated)
September 11, 2028
Last Updated
September 5, 2025
Record last verified: 2025-09