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.
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Crivelli Lucia, Suemoto Claudia Kimie, Sosa Ana Luisa, Lopera Francisco, Aguillón David, Allegri Ricardo Francisco, Nitrini Ricardo, Calandri Ismael Luis, Velilla-Jiménez Lina, Yassuda Mônica Sanches, Acosta-Baena Natalia, Salinas Rosa María, Charamelo Ana, Derio Carolina Delgado, Acosta Daisy Miguelina, León-Salas Jorge Mario, Duque-Peñailillo Lissette, Cusicanqui María Isabel, Custodio Nilton, Anchia-Alfaro Adriana, Núñez-Herrera Alberto, Rubens Alejandra De, Leites Alice, Vigil-Martínez Ana, Damian Andrés, Flores-Blanco Beatriz María, Custodio Belén, Laforcada Carlos, Márquez Carlos, Friedlaender Clarisse Vasconcelos, Espinoza-Cruz Clara Gabriela, Cañadas Cristina, Peixoto Cristiane, Muñoz Darina Helen, Slezak Diego Fernández, Felix Elainy, Aguirre-Salvador Esteban, Surace Ezequiel Ignacio, Mariani Francesca, De La Torre Gabriela Rojas, Verástegui Graciet, Keller Greta, Peixoto Gustavo Henrique, Morilla Handel Arturo, Jiménez-Velázquez Ivonne Z, More Jamileth Yasmín, Rodríguez Javiera Francisca, Tosatti Jéssica Abdo Gonçalves, de Faria Rocha João Victor, Saldarriaga-Hernández Jonathan, Huilca José Carlos, García-Molina José Tomás, Martínez-Galindo Joyce Graciela, Duran Juan Carlos, Rodriguez Juana Guillermina, Gomes Karina Braga, César-Freitas Karolina Gouveia, Agüero Katherine, Mora-Villalobos Lara, Asprilla Laura Osorio, de Souza Leonardo Cruz, Soto Ligia, Cortabarría Lucia, Baldeón Lucy, Carreira Luzia Lima, Marin-Buitrago Lizeth, Moreno Maira Camila, Barbosa Maira Tonidandel, Torheim Maren, Magalhães Maria Aquimara Zambone, da Graça Morais Martin Maria, Martin Maria Eugenia, Torres Melissa Francisca, Menéndez Mercedes, Hernandez Micaela Anahi, Granizo Mónica Sánchez, Gutiérrez Myriam, Corvalán Nicolás, Mora Paula Jimena, Peguero Pedro, Ramírez-Santos Rocío, Fernández Rodrigo Sebastian, Montesinos Rosa, Ospina-Henao Sebastian, Montes Silvia Ysabel, Santero Sofía, Brucki Sonia Maria Dozzi, Josephy-Hernandez Sylvia, Vazquez Tomas Casildo, Bérgamo Yanina, Bocanegra Yamile, Muñoz Yleana Altagracia, Vicuña Yosselin, Lora Zoraida Del Carmen, Kivipelto Miia, Raman Rema, Espeland Mark A, Baker Laura D, Snyder Heather M, Sevlever Gustavo Emilio, Carrillo María C, Caramelli Paulo, LatAm-FINGERS Study Group
Аннотация
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.