[Is dementia preventable through intensive vascular care? The preDIVA trial]

OBJECTIVE: To assess whether intensive vascular care in GP practices can prevent dementia in a population of community-dwelling older people. METHOD: This pragmatic cluster-randomised open-label study (ISRCTN29711771) was conducted in persons aged 70-78 years who were registered with Dutch GP practices. The only exclusion criteria were a diagnosis of dementia and limited life expectancy. Practices were randomly assigned to an intervention arm or a control arm. Participants in the interventional arm underwent a cardiovascular check-up every 4 months for six years by a practice nurse. Primary outcomes were cumulative incidence of dementia and functional limitations. Main secondary outcomes were the incidence of cardiovascular disease and mortality. RESULTS: Between June 2006 and March 2009, 116 GP practices (3526 participants) were recruited and randomly assigned: 63 (1890 participants) to the intervention group and 53 (1636 participants) to the control group. Primary outcome data were obtained for 3454 (98%) participants; median follow-up was 6.7 years. In this period, dementia was diagnosed in 121/1853 (6.5%) participants in the intervention group and in 112/1601 (7.0%) participants in the control group. This difference was not significant (hazard ratio 0.92, 95% CI 0.71-1.19). No differences were found with regard to functional decline, incident cardiovascular disease and mortality. CONCLUSION: Long-term intensive vascular care for community-dwelling elderly patients, provided in a primary care setting, does not result in a reduced incidence of dementia, functional limitations or mortality. There is, however, possibly an effect in elderly patients with untreated or sub-optimally treated hypertension; this warrants further research.