Tainta Mikel, Ecay-Torres Mirian, Barandiaran Myriam, Estanga Ainara, López Carolina, Altuna Miren, Iriondo Ane, Saldias Jon, Garcia-Sebastian Maite, Cañada Marta, de Arriba Maria, Reparaz-Escudero Imanol, Sáez de Asteasu Mikel L, 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
Centre for Research and Memory Clinic, CITA-alzheimer Foundation, Donostia-San Sebastián, País Vasco, Spain.
Osakidetza, Organización Sanitaria Integrada (OSI) Goierri-Urola Garaia, Goierri-Urola Garaia, País Vasco, Spain.
Front Aging Neurosci. 2025 Jun 16;17:1539711. doi: 10.3389/fnagi.2025.1539711. eCollection 2025.
INTRODUCTION: Growing research suggests that dementia is a complex disorder with multiple 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: It 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 -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: Recruitment has been completed with 1051 participants selected (mean age (standard deviation, SD) of 69.65 (6.36), 58,50 % female, and mean CAIDE (SD) of 7.62 (1.427). The final participant is expected to complete the last study visit by the autumn of 2026. DISCUSSION: 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.
引言：越来越多的研究表明，痴呆症是一种具有多种风险因素和病因的复杂疾病。芬兰预防认知障碍和残疾老年干预研究（FINGER）表明，生活方式干预可带来认知益处。受此启发，GOIZ-ZAINDU（GZ）可行性研究将FINGER方法应用于巴斯克地区。基于GZ研究，CITA GO-ON试验旨在通过风险因素管理和恢复力促进的多领域干预，加强和扩大支持痴呆症预防的证据。 方法：这是一项为期两年的基于人群的随机对照试验，旨在预防心血管危险因素、衰老和痴呆症（CAIDE）风险评分≥6、无痴呆症且在三项认知筛查测试中至少一项表现低于预期的60-85岁成年人的认知能力下降。参与者被随机分配（1:1）接受常规健康建议（RHA）或多领域干预（MD-Int），多领域干预包括认知训练、社会情感技能、多组分体育锻炼、营养和烹饪干预，以及心血管风险、药物管理不当和合并症监测。主要结局是通过改良神经心理测试电池的全球综合评分衡量的干预措施降低认知能力下降风险的疗效。次要结局衡量成本效益、生活质量和功能能力。还将收集血样和脑成像数据，以评估干预措施对脑结构和血浆生物标志物的影响。 结果：已完成招募，共选择了1051名参与者（平均年龄（标准差，SD）为69.65（6.36），58.50%为女性，平均CAIDE（SD）为7.62（1.427）。预计最后一名参与者将于2026年秋季完成最后一次研究访问。 讨论：作为全球FINGERS网络的一部分，CITA GO-ON研究旨在验证多领域生活方式干预对预防痴呆症的疗效，并为制定促进健康、积极老龄化的公共卫生策略提供有价值的数据。
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