Multidomain Vascular Care Intervention to Prevent Dementia
What is the impact of a multidomain intervention targeting cardiovascular risk factors on preventing dementia in a population of community-dwelling older people?
PreDIVA was an open-label, cluster-randomized controlled trial; the investigators recruited individuals ages 70-78 years through participating general practices in the Netherlands. General practices within each health care center were randomly assigned (1:1), via a computer-generated randomization sequence, to either a 6-year nurse-led, multidomain cardiovascular intervention or control (usual care). The primary outcomes were cumulative incidence of dementia and disability score (Academic Medical Center Linear Disability Score [ALDS]) at 6 years of follow-up. The main secondary outcomes were incident cardiovascular disease and mortality. Outcome assessors were masked to group assignment. Analyses included all participants with available outcome data.
Between June 7, 2006, and March 12, 2009, 116 general practices (3,526 participants) within 26 health care centers were recruited and randomly assigned: 63 (1,890 participants) were assigned to the intervention group and 53 (1,636 participants) to the control group. Primary outcome data were obtained for 3,454 (98%) participants; median follow-up was 6.7 years (21,341 person-years). Dementia developed in 121 (7%) of 1,853 participants in the intervention group and in 112 (7%) of 1,601 participants in the control group (hazard ratio [HR], 0.92; 95% confidence interval [CI], 0.71-1.19; p = 0.54). Mean ALDS scores measured during follow-up did not differ between groups (85.7 [standard deviation 6.8] in the intervention group and 85.7 [7.1] in the control group: adjusted mean difference, −0.02; 95% CI, −0.38 to 0.42; p = 0.93). Of the 1,885 participants, 309 (16%) died in the intervention group, compared with 269 (16%) of 1,634 participants in the control group (HR, 0.98; 95% CI, 0.80-1.18; p = 0.81). Incident cardiovascular disease did not differ between groups (273 [19%] of 1,469 participants in the intervention group and 228 [17%] of 1,307 participants in the control group; HR, 1.06; 95% CI, 0.86-1.31; p = 0.57).
The authors concluded that a nurse-led, multidomain intervention did not result in a reduced incidence of all-cause dementia in an unselected population of older people.
This study reports no effect of a nurse-led intensive vascular care intervention on incident all-cause dementia. There was also no effect on mortality, cardiovascular disease, or disability, despite a greater improvement in systolic blood pressure in the intervention group compared with the control group. This lack of benefit could be a result of insufficient contrast between study groups, or perhaps by lack of causal interaction with the neurodegenerative changes that underlie Alzheimer’s disease. It should be noted that these results do not rule out clinically meaningful effects in people with untreated hypertension who are adherent to the intervention, and needs to be tested in future studies.
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