Lowering blood pressure to slow brain lesions in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to determine if reducing blood pressure can slow the progression of White Matter Lesions (WML) in elderly patients experiencing cognitive complaints. It involves a prospective randomized open blinded endpoint design, where participants will be divided into two groups: one receiving an enhanced blood pressure management strategy and the other receiving usual care. The study will enroll 820 patients across multiple Memory Resources and Research Centers, with evaluations including MRI scans to assess changes in WML over time.

Why it matters

Who can join: the full rules

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

Exclusion Criteria:

* 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

Where it's running

• Memory Resources Centre and South of Ile de France Search - Broca Hospital
  Paris, France Recruiting
• Memory for Research and Resources Center / Neuroscience pole
  Bordeaux, Pellegrin Hospital Group, France Not yet recruiting

Study contacts

• Principal investigator: Olivier HANON, MD, PhD — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Olivier HANON, MD, PhD
• Email: olivier.hanon@brc.aphp.fr
• Phone: 33 1 44 08 35 02

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.