About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
60 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).
Disqualifiers
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 ...)
Trial design
Parallel
Treatments tested in this trial
blood pressure lowering algorithm
Other interventionThe 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.
usual strategy
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Imaging criteria : changes in the number of large or confluent WML
Imaging criteria : changes in the volume of WML depending on their location (periventricular and deep white matter)
Imaging criteria : changes in the number of silent infarctus
Imaging criteria : changes in the number of microbleeds
Sponsors and contacts
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