S4‐01‐02: Intensive vascular care in dementia prevention (EVA and preDiva trials)

Abstract

Vascular risk factors are associated with an increased risk of dementia. Epidemiological studies suggest that cognitive decline and dementia can be postponed or prevented by treatment of these risk factors. In the randomized controlled EVA-study (Evaluation of Vascular Care in Alzheimer's Disease) we have shown that intensive vascular care slows progression of white matter lesions in early AD, but this is not accompanied by a clinically relevant effect on cognition, behaviour or handicap. Earlier intervention before the onset of cognitive decline might be needed. The Prevention of Dementia by Intensive Vascular Care (PreDIVA) study is a cluster-randomized clinical trial in 3534 non-demented elderly (70-78 years) comparing intensive vascular care to standard care with a 6-year intervention and follow-up. The intervention consists of 4-monthly visits to a practice nurse who addresses all vascular risk factors (hypertension, dyslipidemia, DM, obesity, smoking, lack of physical exercise) and initiates and monitors pharmacological and non-pharmacological treatments in close collaboration with the general practitioner. Primary outcomes are incident dementia and handicap. Main secondary outcomes are cardiovascular events (stroke, myocardial infarction, peripheral arterial disease), mortality and depression. Repeated structural MRI is done in a subset. At baseline only 12% of participants had no risk factors amenable to treatment, >40% had 2 or more risk factors, 39% had a systolic BP >160 mmHg and 23% had a BMI >25. In early 2012 the 2-year follow-up will be complete. Preliminary data show a reduction of the systolic blood pressure of 8.5 vs 4.9 mmHg in the intervention vs. control group. The use of antihypertensive drugs increased by 16% vs. 9%. Further analysis of the effect on vascular risk profile is ongoing and will be presented. A full interim analysis of the effect on the primary outcomes dementia and handicap will take place after 4 years of intervention and follow-up. Large-scale nurse-led intensive vascular care is feasible and leads to improved management of hypertension, and potentially other vascular risk factors. Whether this will lead to prevention of cognitive decline and dementia will be answered by the Prevention of Dementia by Intensive Vascular Care (PreDIVA) study.