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Study to Slow Progression of Brain Vessel Damage by Lowering Blood Pressure in Older Adults with Cognitive Complaints
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-09-05
820
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether lowering blood pressure can slow the progression of White Matter Lesions WML in older adults who have cognitive complaints and moderate to high levels of these brain abnormalities seen on MRI. WML are linked to a higher risk of dementia, especially Alzheimers disease, and high blood pressure is a major risk factor for developing these lesions. This study tests if enhanced blood pressure control can reduce WML progression compared to usual care. Participants will be randomly assigned to one of two groups an enhanced strategy group aiming to lower systolic blood pressure to below 135 mmHg using antihypertensive medications following national and international guidelines, or a usual care group receiving standard blood pressure management. The choice of specific drugs is left to the investigators. The study includes an initial MRI at the start and a follow-up MRI after about 36 months to assess brain changes. During the study, participants will undergo yearly neuropsychological tests, walking speed and balance assessments, repeated blood pressure measurements, and monitoring for neurological symptoms. Blood tests will be done at baseline, and MRI scans will confirm eligibility and measure lesion volume changes. The main outcome is the change in WML volume after approximately three years. Other outcomes include brain volume changes, cognitive performance, incidence of dementia and vascular events, and mortality. Total participation lasts about 3.5 years, with close monitoring throughout.
CONDITIONS
Brief Title
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Research Team
O
Olivier HANON, MD, PhD
C
Christophe TZOURIO, MD, PhD
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