GOIZ ZAINDU trial: a FINGER-like multidomain lifestyle intervention feasibility study to prevent dementia in Southern Europe.

Background: GOIZ ZAINDU ("caring early" in Basque) is a pilot study to adapt the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) methodology to the Basque population and evaluate feasibility and adherence to a FINGER-like multidomain intervention program. Additional aims included the assessment of efficacy on cognition and collecting data to design a large efficacy trial. Method: GOIZ ZAINDU is a one-year, randomized, controlled trial of a multidomain intervention in persons aged 60+ years, with Cardiovascular Risk Factors, Aging and Dementia (CAIDE) risk score ≥ 6, no dementia, and below-than-expected performance in at least one of three cognitive screening tests. Randomization to a Multidomain intervention (MD-Int) or Regular Health Advice (RHA) was stratified by sex, age (>/≤ 75), and cognitive status (Mild Cognitive Impairment (MCI)/normal cognition). MD-Int included cardiovascular risk factors control, nutritional counseling, physical activity, and cognitive training. The primary outcome was retention rate and adherence to the intervention program. Exploratory cognitive outcomes included Neuropsychological Test Battery z-scores change. Analyses were carried out by intention to treat. Results: One hundred twenty-five participants were recruited (mean age: 75.64 (±6.46); 58% women). MD-Int (n=61) and RHA (n=64) groups were balanced in demographics and cognition. 52 (85%) participants from RHA and 56 (88%) from the MD-Int group completed the study. More than 70% of participants presented good overall adherence to intervention activities. The risk of cognitive decline was higher in the RHA group compared with MD-Int regarding executive function (p=.019) and processing speed scores (p=.026). Conclusions: The GOIZ-ZAINDU study has proved that the FINGER methodology is adaptable and feasible in a different socio-cultural environment. Exploratory efficacy results show a lower risk of decline in executive function and processing speed. These results support the design of a large-scale efficacy trial.