Multidomain lifestyle intervention for the prevention of cognitive decline in at-risk older adults in Latin America (LatAm-FINGERS): a single-blind, multicentre, randomised controlled trial.

Multidomain lifestyle interventions might delay cognitive decline, but populations from Latin America remain under-represented in dementia prevention trials.

多领域的生活方式干预可能能延缓认知能力的下降，但在痴呆症预防试验中，拉丁美洲人群的代表性仍然不足。

We aimed to investigate the feasibility of a culturally adapted, multidomain, systematic lifestyle intervention and investigate its effects on global cognitive function in at-risk older adults (aged 60-77 years).

我们的目标是研究一种文化适应的、多领域的系统生活方式干预的可行性，并探讨其对有风险的老年人（60-77岁）全球认知功能的影响。

Methods

The LatAm-FINGERS Initiative for Cognitive Change (hereafter referred to as LatAm-FINGERS) was a single-blind, multicentre, randomised clinical trial conducted in 11 Latin American countries (Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Peru, and Uruguay).

LatAm-FINGERS倡议（以下简称LatAm-FINGERS）是在11个拉丁美洲国家（阿根廷、玻利维亚、巴西、智利、哥伦比亚、哥斯达黎加、多米尼加共和国、厄瓜多尔、墨西哥、秘鲁和乌拉圭）进行的一项单盲、多中心、随机临床试验。

Individuals aged 60-77 years with high risk of dementia (cardiovascular risk factors, ageing, and dementia risk score ≥6), and suboptimal cognitive performance were randomly assigned (1:1) to receive either a 2-year systematic lifestyle intervention (SLI group) or a flexible lifestyle intervention (FLI group).

年龄在60-77岁之间，具有高痴呆风险（心血管风险因素、老龄化和痴呆风险评分≥6）以及亚最佳认知表现的个体被随机分配（1:1）接受为期2年的系统性生活方式干预（SLI组）或灵活生活方式干预（FLI组）。

Randomisation was stratified by the study centre to ensure balance and implemented using permuted blocks of eight.

随机分组按研究中心进行分层，以确保平衡，并使用八人一组的置换块方法实施。

Participants and intervention staff were not masked to group assignment, but individuals who assessed outcomes were masked throughout the trial. The SLI provided structured multidomain lifestyle interventions with supervised support and monitoring; FLI offered health advice.

参与者和干预工作人员未对分组进行盲法处理，但评估结果的人员在整个试验过程中保持盲法。SLI提供了结构化的多领域生活方式干预，包括监督支持和监测；FLI提供了健康建议。

Primary outcomes were trial feasibility (evaluated using selected RE-AIM measures: Reach, Implementation, and Maintenance) and the intervention's effects on global cognitive composite trajectories over 2 years (change in the global cognitive composite score over 2 years).

主要结果是试验的可行性（使用选定的RE-AIM指标进行评估：接触度、实施度和维持度）以及干预措施在2年内对全球认知综合轨迹的影响（2年内全球认知综合评分的变化）。

This trial is registered at ClinicalTrials.gov (NCT06492967) and has been completed.

该试验已在ClinicalTrials.gov注册（NCT06492967），并已完成。

Results

Participants were enrolled between Oct 27, 2021, and July 7, 2023; the last participant completed follow-up on Nov 7, 2025.

参与者在2021年10月27日至2023年7月7日期间被纳入；最后一名参与者在2025年11月7日完成了随访。

Among 1719 assessed, 1065 participants included in the analytic sample were randomly assigned to the SLI group (n=539) or the FLI group (n=526).

在评估的1719名参与者中，有1065名被纳入分析样本，并随机分配到SLI组（n=539）或FLI组（n=526）。

Mean age was 67·5 years (SD 4·7), 795 (75%) of 1065 participants were women, and 270 (25%) were men.

平均年龄为67.5岁（标准差4.7），1065名参与者中有795名（75%）为女性，270名（25%）为男性。

Self-reported race and ethnicity were: 624 (59%) Mestizo, 288 (27%) White, 72 (7%) Mulatto, 25 (2%) Mixed or other, 18 (2%) Black, 14 (1%) Indigenous, and 24 (2%) did not report race or ethnicity. 877 (82·3%) of 1065 completed the 2-year follow-up.

自我报告的种族和民族分布如下：624人（59%）为梅斯蒂索人，288人（27%）为白人，72人（7%）为穆拉托人，25人（2%）为混合或其他，18人（2%）为黑人，14人（1%）为原住民，24人（2%）未报告种族或民族。1065名完成者中有877人（82.3%）完成了2年的随访。

Recruitment effectiveness (Reach) was 62·0%; mean adherence to the SLI group (Implementation) was 71·6% over the entire trial; and frequencies of complete cognitive outcomes data (Maintenance) were 87·9% at 6 months, 85·3% at 12 months, 81·4% at 18 months, and 84·8% at 24 months in the SLI group compared with 86·3% at 6 months, 78·9% at 12 months, 73·4% at 18 months, and 79·8% at 24 months in the FLI group.

招募有效性（Reach）为62.0%；整个试验期间，SLI组的平均依从性（Implementation）为71.6%；SLI组在6个月时完全认知结果数据的频率（Maintenance）为87.9%，12个月时为85.3%，18个月时为81.4%，24个月时为84.8%，而FLI组在6个月时为86.3%，12个月时为78.9%，18个月时为73.4%，24个月时为79.8%。

Dropouts were higher in the FLI group than in the SLI group (20·2% vs 15·2%; p=0·042).

FLI组的脱落率高于SLI组（20.2% vs 15.2%；p=0.042）。

Global cognitive composite scores increased over time in both groups, with a mean annual change of 0·31 SD (95% CI 0·28-0·34) per year in the SLI group and 0·20 SD (0·17-0·23) per year in the FLI group (mean between-group difference of 0·11 SD per year [0·06-0·15; p<0·0001]).

两组的全球认知综合评分随时间增加，SLI组的平均年增长为0.31标准差（95% 置信区间 0.28-0.34），FLI组为0.20标准差（0.17-0.23），两组间平均差异为每年0.11标准差（0.06-0.15；p<0.0001）。

Overall, 478 adverse events were reported (412 in the SLI group and 66 in the FLI group).

总体而言，报告了478起不良事件（SLI组412起，FLI组66起）。

The most common adverse events were musculoskeletal symptoms (113 [21%] in the SLI group, 13 [2%] in the FLI group), upper respiratory infections (50 [9%] in the SLI group, one [<1%] in the FLI group), and COVID-19 infection (31 [6%] events in the SLI group).

最常见的不良事件是肌肉骨骼症状（SLI组113起，占21%，FLI组13起，占2%），上呼吸道感染（SLI组50起，占9%，FLI组1起，少于1%），以及COVID-19感染（SLI组31起，占6%）。

Serious adverse events occurred in 50 (9%) participants in the SLI group and 24 (5%) participants in the FLI group; none were related to the intervention.

在SLI组中有50名（9%）参与者发生了严重不良事件，在FLI组中有24名（5%）参与者发生了严重不良事件；这些均与干预措施无关。

There were eight deaths (three in the SLI group and five in the FLI group), and none were related to the intervention.

共有八名参与者死亡（SLI组三名，FLI组五名），且均与干预措施无关。

interpretation

A culturally adapted multidomain lifestyle intervention was feasible across Latin America and resulted in greater cognitive improvements than a flexible health-advice intervention in older adults at risk of cognitive decline.

一种经过文化适应的多领域生活方式干预在拉丁美洲是可行的，并且在有认知衰退风险的老年人中比灵活的健康建议干预带来了更大的认知改善。

These findings extend the evidence base for multidomain lifestyle interventions to populations historically under-represented in dementia research, supporting their feasibility and scalability as strategies to reduce cognitive decline risk amid the rapidly growing burden of dementia in low-income and middle-income countries.

这些发现扩展了多领域生活方式干预的证据基础，支持了在历史上在痴呆症研究中代表性不足的人群中的可行性和可扩展性，作为降低认知衰退风险的策略，支持在低收入和中等收入国家中认知衰退风险的快速增加。

funding

Alzheimer's Association.

阿尔茨海默病协会。

translations

For the Spanish and Portuguese translations of the abstract see Supplementary Materials section.

摘要的西班牙语和葡萄牙语翻译请参见补充材料部分。