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Randomized Controlled Trial
. 2023 Sep;19(9):4046-4060.
doi: 10.1002/alz.13101. Epub 2023 May 19.

Latin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline (LatAm-FINGERS): Study design and harmonization

Lucia Crivelli  1 , Ismael Luis Calandri  1 , Claudia Kimie Suemoto  2 , Rosa María Salinas  3 , Lina Marcela Velilla  4 , Mônica Sanches Yassuda  5   6 , Paulo Caramelli  7 , Francisco Lopera  4 , Ricardo Nitrini  5 , Gustavo Emilio Sevlever  1 , Ana Luisa Sosa  3 , Daisy Acosta  8 , Ana María Charamelo Baietti  9   10 , María Isabel Cusicanqui  11 , Nilton Custodio  12   13 , Sergio Dansilio De Simone  10 , Carolina Delgado Derio  14 , Lissette Duque-Peñailillo  15 , Juan Carlos Duran  11 , Ivonne Z Jiménez-Velázquez  16 , Jorge Mario Leon-Salas  17 , Yanina Bergamo  18 , María Florencia Clarens  1 , Andrés Damian  19 , Ignacio Demey  1 , María Belén Helou  1 , Carlos Márquez  20 , María Eugenia Martin  1 , Maria da Graça Morais Martin  21 , Diego Querze  22 , Ezequiel Ignacio Surace  23 , Sabrina Acosta-Egea  17 , Esteban Aguirre-Salvador  15 , Leonardo Cruz de Souza  7 , Gustavo Henrique da Cunha Peixoto Cançado  24 , Sonia Maria Dozzi Brucki  5 , Clarisse Vasconcelos Friedlaender  7 , Karina Braga Gomes  25 , Myriam Gutierrez  26 , Carlos Laforcada Ríos  11 , Joyce Graciela Martinez Galindo  3 , Rosa Montesinos  12 , Alberto Nuñez-Herrera  15 , Sebastián Ospina-Henao  27 , Guillermina Rodríguez  28 , Victoria Ruiz Masson  15 , Mónica Sánchez  15 , Christian E Schenk  29 , Ligia Soto  15 , Maira Tonidandel Barbosa  7 , Jéssica Abdo Gonçalves Tosatti  7 , Yosselin Vicuña  30 , Mark Espeland  31 , Krister Hakansson  32 , Miia Kivipelto  33   34   35 , Laura Baker  36 , Heather Snyder  37 , María Carrillo  37 , Ricardo Francisco Allegri  1   38
Affiliations
Randomized Controlled Trial

Latin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline (LatAm-FINGERS): Study design and harmonization

Lucia Crivelli et al. Alzheimers Dement. 2023 Sep.

Abstract

Introduction: Latin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline (LatAm-FINGERS) is the first non-pharmacological multicenter randomized clinical trial (RCT) to prevent cognitive impairment in Latin America (LA). Our aim is to present the study design and discuss the strategies used for multicultural harmonization.

Methods: This 1-year RCT (working on a 1-year extension) investigates the feasibility of a multi-domain lifestyle intervention in LA and the efficacy of the intervention, primarily on cognitive function. An external harmonization process was carried out to follow the FINGER model, and an internal harmonization was performed to ensure this study was feasible and comparable across the 12 participating LA countries.

Results: Currently, 1549 participants have been screened, and 815 randomized. Participants are ethnically diverse (56% are Nestizo) and have high cardiovascular risk (39% have metabolic syndrome).

Discussion: LatAm-FINGERS overcame a significant challenge to combine the region's diversity into a multi-domain risk reduction intervention feasible across LA while preserving the original FINGER design.

Keywords: Alzheimer's disease; World-Wide FINGERS; cognitive impairment; dementia lifestyle; multidomain intervention; prevention; randomized controlled trial.

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Conflict of interest statement

CONFLICT OF INTEREST STATEMENT

The authors declare no conflicts of interest. Author disclosures are available in the supporting information.

Figures

FIGURE 1
FIGURE 1
On the left, countries that are part of the LatAm-FINGERS trial. On the right, screened and randomized participants by country. LatAm-FINGERS, Latin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline
FIGURE 2
FIGURE 2
Trial summary showing key aspects of inclusion and exclusion criteria, interventions timeline, and outcomes. CAIDE, Cardiovascular Risk Factors, Aging, and Incidence of Dementia; CERAD, Consortium to Establish a Registry for Alzheimer’s Disease; LatAm-FINGERS, Latin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline; MMSE, Mini-Mental State Examination; LatAm-NTB, Latin American Neuropsychological Test Battery; RE-AIM, reach, effectiveness, adoption, implementation, and maintenance
FIGURE 3
FIGURE 3
Organizational chart showing the different roles in the harmonization process. LatAm-FINGERS, Latin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline; WG, working group
See this image and copyright information in PMC

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