O1‐05‐04: A MULTIDOMAIN, TWO‐YEAR, RANDOMIZED CONTROLLED TRIAL TO PREVENT COGNITIVE IMPAIRMENT: THE FINGER STUDY

Observational studies have identified multiple modifiable risk factors associated with increased risk of late-life cognitive impairment and Alzheimer's disease (AD). However, previous smaller and shorter term prevention trials with single-factor interventions have had disappointing or at best modest results. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) investigated the effects of a 2-year multidomain intervention targeting several lifestyle and vascular risk factors simultaneously. FINGER is a 2-year multicenter randomized controlled trial with 1260 participants aged 60-77 years recruited from previous population-based survey cohorts. Inclusion criteria were: CAIDE Dementia Risk Score > 6 points, indicating the presence of modifiable risk factors; and cognitive performance at the mean level or slightly lower than expected for age. Participants were randomized (1:1) into either the multidomain intervention group or the control group. The intervention included nutritional guidance, physical exercise, cognitive training and social activities, and management of vascular risk factors. The control group received regular health advice. Primary outcome after 2 years is cognitive performance measured by a comprehensive neuropsychological test battery (NTB) composite Z score. An extended follow-up (7 years) with a sustenance intervention is planned to evaluate longer-term effects on dementia/AD incidence, and secondary and exploratory outcomes including biomarkers and neuroimaging with MRI and PET. The 2-year intervention was finalized in February 2014. Here we report the main intention-to-treat (ITT) results on cognition after 2 years of intervention. Linear mixed-model statistical analyses were used. We found a significant beneficial intervention effect on overall cognitive performance (NTB) (p < 0.001 for time*group interaction). The beneficial effect was seen on each cognitive domain: memory (p < 0.05); executive function (p < 0.05), and psychomotor speed (p < 0.05). Drop-out rate was only 11%, and participants' experiences were very positive. This is the first large RCT showing that it is possible to prevent cognitive decline using a multidomain intervention among older at-risk individuals. These results highlight the value of the feasible and novel multidomain approach that is effective for several cognitive domains.