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Lancet - 2026-07-13 - Journal Article

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.

Crivelli L, Suemoto CK, Sosa AL, Lopera F, Aguillón D, Allegri RF, Nitrini R, Calandri IL, Velilla-Jiménez L, Yassuda MS, Acosta-Baena N, Salinas RM, Charamelo A, Derio CD, Acosta DM, León-Salas JM, Duque-Peñailillo L, Cusicanqui MI, Custodio N, Anchia-Alfaro A, Núñez-Herrera A, Rubens A, Leites A, Vigil-Martínez A, Damian A, Flores-Blanco BM, Custodio B, Laforcada C, Márquez C, Friedlaender CV, Espinoza-Cruz CG, Cañadas C, Peixoto C, Muñoz DH, Slezak DF, Felix E, Aguirre-Salvador E, Surace EI, Mariani F, De La Torre GR, Verástegui G, Keller G, Peixoto GH, Morilla HA, Jiménez-Velázquez IZ, More JY, Rodríguez JF, Tosatti JAG, de Faria Rocha JV, Saldarriaga-Hernández J, Huilca JC, García-Molina JT, Martínez-Galindo JG, Duran JC, Rodriguez JG, Gomes KB, César-Freitas KG, Agüero K, Mora-Villalobos L, Asprilla LO, de Souza LC, Soto L, Cortabarría L, Baldeón L, Carreira LL, Marin-Buitrago L, Moreno MC, Barbosa MT, Torheim M, Magalhães MAZ, da Graça Morais Martin M, Martin ME, Torres MF, Menéndez M, Hernandez MA, Granizo MS, Gutiérrez M, Corvalán N, Mora PJ, Peguero P, Ramírez-Santos R, Fernández RS, Montesinos R, Ospina-Henao S, Montes SY, Santero S, Brucki SMD, Josephy-Hernandez S, Vazquez TC, Bérgamo Y, Bocanegra Y, Muñoz YA, Vicuña Y, Lora ZDC, Kivipelto M, Raman R, Espeland MA, Baker LD, Snyder HM, Sevlever GE, Carrillo MC, Caramelli P, LatAm-FINGERS Study Group

RCTLOE In = 10652 years

Topics

general
PMID: 42442374DOI: 10.1016/S0140-6736(26)01278-XView on PubMed ->

Key Takeaway

A structured multidomain lifestyle intervention produced a 0.11 SD/year greater improvement in global cognitive composite scores versus flexible health advice in at-risk Latin American older adults (p<0.0001).

Summary Depth

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Summary

LatAm-FINGERS randomized 1065 adults aged 60–77 with elevated dementia risk (CAIDE score ≥6) across 11 Latin American countries 1:1 to a structured multidomain lifestyle intervention (SLI) or flexible health advice (FLI) for 2 years. The SLI achieved 71.6% adherence and 82.3% overall 2-year completion; dropout was lower in SLI than FLI (15.2% vs 20.2%, p=0.042). Global cognitive composite scores improved 0.31 SD/year in SLI versus 0.20 SD/year in FLI, a between-group difference of 0.11 SD/year (95% CI 0.06–0.15, p<0.0001).

Key Limitation

Both groups showed cognitive score increases over time, raising the possibility that practice effects from repeated neuropsychological testing—rather than true cognitive improvement—account for a portion of the observed between-group difference.

Original Abstract

BACKGROUND

Latin America faces a high dementia burden, with increased prevalence of factors associated with cognitive decline. Multidomain lifestyle interventions might delay cognitive decline, but populations from Latin America remain under-represented in dementia prevention trials. 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).

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). 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). Randomisation was stratified by the study centre to ensure balance and implemented using permuted blocks of eight. 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. 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). This trial is registered at ClinicalTrials.gov (NCT06492967) and has been completed.

FINDINGS

Participants were enrolled between Oct 27, 2021, and July 7, 2023; the last participant completed follow-up on Nov 7, 2025. 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). Mean age was 67·5 years (SD 4·7), 795 (75%) of 1065 participants were women, and 270 (25%) were men. 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. 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. Dropouts were higher in the FLI group than in the SLI group (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]). Overall, 478 adverse events were reported (412 in the SLI group and 66 in the FLI group). 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). 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. There were eight deaths (three in the SLI group and five in the FLI group), and none were related to the intervention.

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. 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.

FUNDING

Alzheimer's Association.

TRANSLATIONS

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