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

Department of Cognitive Neurology, Fleni, Buenos Aires, Argentina. Division of Geriatrics, University of São Paulo Medical School, São Paulo, Brazil. Laboratorio de Demencias del Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, Ciudad de México, México. Neuroscience Group of Antioquia Medical School, Antioquia University, Medellín, Colombia. Cognitive and Behavioral Neurology Unit, Department of Neurology, University of São Paulo School of Medicine, São Paulo, Brazil. Gerontology, School of Arts, Sciences, and Humanities, University of São Paulo, São Paulo, Brazil. Behavioral and Cognitive Neurology Unit, Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil. Internal Medicine Department, Universidad Nacional Pedro Henriquez Urena (UNPHU), Santo Domingo, Dominican Republic. Clínica de la Memoria-Hospital Británico, Montevideo, Uruguay. Departamento de Neuropsicología, Facultad de Medicina-Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay. Centro Neurológico Mente Activa, La Paz, Bolivia. Unidad de Diagnóstico de Deterioro Cognitivo y Prevención de Demencia, Instituto Peruano de Neurociencias, Lima, Perú. Escuela Profesional de Medicina Humana, Universidad Privada San Juan Bautista, Lima, Perú. Unidad de Cerebro Saludable, Departamento de Neurología y Neurocirugía, Hospital Clínico Universidad de Chile, Santiago de Chile, Chile. Cognitive Disorders Unit-Neuromedicenter, Quito, Ecuador. Centro de Investigación en Geriatría, Departamento de Medicina Interna, Recinto de Ciencias Médicas, Universidad de Puerto Rico, San Juan, Puerto Rico. Departamento de Investigación Clínica, Life Science Research Institute, Hospital Clínica Bíblica, San José, Costa Rica. Department of Diagnostic Imaging, Fleni, Buenos Aires, Argentina. CUDIM Centro Uruguayo de Imagenología Molecular, Montevideo, Uruguay. Instituto de Nutrición y Tecnología de los Alimentos, Universidad de Chile, Santiago de Chile, Chile. Department of Radiology HCFMUSP, University of São Paulo School of Medicine, São Paulo, Brazil. Department of Neurology, Fleni, Buenos Aires, Argentina. Department of Molecular Biology and Bioinformatics, Fleni, Buenos Aires, Argentina. Escola de Educação Física, Fisioterapia e Terapia Ocupacional, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil. Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil. Unidad de Cerebro Saludable, Departamento de Neurociencia, Facultad de Medicina, Universidad de Chile, Santiago de Chile, Chile. Facultad de Medicina, Universidad de Ciencias Médicas, Instituto de Investigación en Ciencias Médicas, San José, Costa Rica. Department of Demography and Biostatistics, Ministry of Public Health, Santo Domingo, Dominican Republic. Neurology Division, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico. Inbiomed (Instituto de Investigación en Biomedicina), Universidad Central del Ecuador, Quito, Ecuador. Departments of Internal Medicine and Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA. Division of Clinical Geriatrics, Karolinska Institutet, Stockholm, Sweden. Division of Clinical Geriatrics, Centre for Alzheimer Research, Karolinska Institutet and Theme Inflammation and Aging, Karolinska University Hospital, Stockholm, Sweden. Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland. Ageing Epidemiology Research Unit, School of Public Health, Imperial College London, London, UK. Departments of Internal Medicine, Neurology, and Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA. Alzheimer's Association, Chicago, Illinois, USA. Department of Neurosciences, Universidad de la Costa (CUC), Barranquilla, Colombia.

Alzheimer's & dementia : the journal of the Alzheimer's Association. 2023;(9):4046-4060

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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.

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