Title: CITA GO-ON Study. A community based Multidomain Lifestyle Intervention to prevent cognitive decline. Protocol design and study progress
Authors: Tainta Mikel , Ecay-Torres Mirian , Estanga Ainara , Lopez Carolina , Barandiaran Myriam , Altuna Miren , Iriondo Ane , Saldias Jon , Garcia-Sebastian Maite , Cañada Marta , de Arriba Maria , Reparaz-Escudero Imanol , de Asteasu Mikel L. Sáez , Izquierdo Mikel , Balluerka Nekane , Gorostiaga Arantxa , Ros Naia , Soroa Goretti , Domper Jara , Gayoso Lucia , Arrizabalaga-Lopez Maria , Etxeberria Usune , Torres Maria Ines , Alberdi Elena , Capetillo-Zarate Estibaliz , Mateo-Abad Maider , Vergara Itziar , Mar Javier , Martinez-Lage Pablo 
Published: July 2024

Abstract

BACKGROUND: Accumulating evidence supports the notion that dementia is a multifactorial condition with various risk factors and causes. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) demonstrated that lifestyle interventions could confer cognitive benefits. Inspired by this, the GOIZ-ZAINDU (GZ) feasibility study adapted the FINGER approach to the Basque context. Building upon the GZ study, the CITA GO-ON trial aims to enhance and expand the evidence supporting dementia prevention through a multidomain intervention of risk factor management and resilience promotion.
METHODS: The CITA GO-ON Study is a two-year, population-based, randomized controlled trial to prevent cognitive decline in adults aged 60–85 years with Cardiovascular Risk Factors, Aging and Dementia (CAIDE) risk score ≥ 6, no dementia, and below-than-expected performance on at least one of three cognitive screening tests. Participants are randomized (1:1) to receive either Regular Health Advice (RHA) or a Multidomain Intervention (MD-Int) that encompasses cognitive training, socio-emotional skills, multicomponent physical exercise, nutritional and culinary intervention, and monitoring for cardiovascular risks, pharmacological drug mismanagement, and comorbidities. The primary outcome is the efficacy of the intervention to reduce the risk of cognitive decline measured by the global composite z-score of the modified Neuropsychological Test Battery over two years. The secondary outcomes measure cost-effectiveness, quality of life, and functional abilities. Blood samples and brain imaging will also be collected to evaluate the effects of the intervention on brain structure and plasma biomarkers.
RESULTS:From December 2021 to January 2024, 980 participants have been enrolled (mean age (standard deviation, SD) of 69.40 (6.31), 49.20 % female, mean CAIDE (SD) of 7.6 (1.41), and mean MMSE (SD) of 28.14 (1.92)). Half of the cohort (n = 451) has already been randomized at this time, and the recruitment phase is expected to be concluded in fall of 2024. The final participant is expected to complete the last study visit by the autumn of 2026.
CONCLUSION: The CITA GO-ON Study, as a part of the World-Wide FINGERS network, is designed to validate the efficacy of a multidomain lifestyle intervention for dementia prevention and contribute valuable data to inform public health strategies fostering healthy, active aging.
Trial registration: The CITA GO-ON study was registered at ClinicalTrials.gov (NCT04840030) on March 26, 2021.