A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 25771249 · doi:10.1016/S0140-6736(15)60461-5
What was done
A double-blind, multicenter randomized controlled trial (FINGER) evaluated 1,260 older adults aged 60–77 years recruited from Finnish national surveys. Eligible participants had a CAIDE dementia risk score of at least 6 points and cognitive performance at or slightly below age-expected norms. Participants were randomized 1:1 to either a 2-year multidomain intervention comprising dietary counseling, physical exercise, cognitive training, and vascular risk monitoring (n=631), or a control group receiving general health advice (n=629). Outcome assessors were masked to group allocation. The primary outcome was cognitive change measured by a comprehensive neuropsychological test battery (NTB) total Z score over 2 years, analyzed using a modified intention-to-treat approach (participants with at least one post-baseline assessment).
What was found
A total of 1,190 participants were included in the modified intention-to-treat analysis (591 intervention, 599 control). Estimated mean change in NTB total Z score at 2 years was 0.20 (SE 0.02, SD 0.51) in the intervention group versus 0.16 (SE 0.01, SD 0.51) in the control group. The between-group difference in the change of NTB total score per year was 0.022 (95% CI 0.002 to 0.042, p=0.030). Overall trial dropout was 12% (153 participants). Adverse events occurred in 46 (7%) intervention participants compared to 6 (1%) controls, most frequently musculoskeletal pain (32 [5%] in the intervention group vs 0 in the control group).
Why it matters
This trial demonstrates that simultaneously targeting multiple modifiable lifestyle and vascular risk factors can maintain or modestly improve cognitive function in at-risk older adults.
Limits
The study was conducted exclusively in Finnish older adults selected for elevated CAIDE risk scores, limiting generalizability to other populations or lower-risk groups. Because the intervention was bundled, the study design cannot isolate the individual contribution of diet, exercise, cognitive training, or vascular monitoring. The between-group effect size on the NTB score was modest, and the 2-year duration was insufficient to evaluate reduction in clinical dementia incidence.
Cited by
- supports The FINGER trial in Finland and its US replication, the POINTER trial, evaluated multidomain lifestyle interventions comprising diet, exercise, cardiovascular risk factor monitoring and treatment, and cognitive brain training in older adults.