Informations générales (source: ClinicalTrials.gov)
LEukoaraiosis and blOod Pressure Reduction in OLD People
Interventional
Phase 4
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2015
septembre 2028
18 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:46:18 | Contacter | |||
| AP-HP - Hôpital Broca-La Rochefoucauld-La Collégiale | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Memory for Research and Resources Center / Neuroscience pole - 33076 - Bordeaux - Pellegrin Hospital Group - France | Christophe Tzourio, MD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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).
- 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
- 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).
- 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
- 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
- Patient participating in another clinical research study on drug requiring exclusion
period
- severe renal impairment