Inclusive Clinical Trials in Alzheimer’s Disease: A Latin American Perspective from LatAm FINGERS

Abstract Background The LatAm‐FINGERS trial marks a pioneering initiative as the first non‐pharmacological clinical trial encompassing participants from 12 Latin American countries, including Argentina, Brazil, Bolivia, Chile, Colombia, Costa Rica, Ecuador, Dominican Republic, Mexico, Peru, Puerto Rico, and Uruguay. This initiative represents a significant advancement in promoting inclusivity and diversity in clinical trial recruitment, particularly in underserved populations. Method The LatAm‐FINGERS trial is a multicenter randomized clinical trial evaluating a lifestyle intervention tailored for the Latin American population. Innovative and culturally sensitive recruitment methods were employed, utilizing social media, community outreach, and partnerships with religious groups to ensure inclusivity. The multidomain intervention includes diet, physical exercise, cognitive training, and health coaching and socialization. The intervention was delivered in teams of ten, with adherence strategies including moderated chat groups, dietary adaptations to local customs, shared cultural celebrations, recognition awards, personalized video tutorials, engagement calls, and motivational elements. These approaches facilitated participant retention and engagement despite socio‐economic challenges. Result Despite challenges such as transportation difficulties and risks of violence in certain regions, the trial effectively implemented prevention strategies across a diverse demographic spectrum. Recruitment for LatAm‐FINGERS began in December 2021. To date, 1186 participants (98.8%) have been randomized into the intervention group. The average age of participants is 69 (SD = 2.5) years, with an average educational level of 12.4 (SD = 3.4) years, and an MMSE score of 27.32 (SD = 1.68). The diversity of the Latin American population is evident in the self‐reported ethnicity data: 57.1% Mestizo, 27.7% White, 5.5% Mixed, 2% Black, 1% Native American, and 5.7% other. Conclusion Preliminary findings from LatAm‐FINGERS highlight the feasibility of conducting intervention trials within diverse populations. These findings underscore the importance of creating recruitment strategies that effectively engage underrepresented groups. This contributes significantly to global Alzheimer’s disease research efforts. The trial’s experience offers a valuable model for inclusive enrollment practices in Alzheimer’s disease and related dementia research, aligning with contemporary trends toward equitable and evidence‐based trial design.

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Publication Details

Journal
Alzheimer s & Dementia
Published
2024-12-01
DOI
https://doi.org/10.1002/alz.085948
Primary Topic
Ethics in Clinical Research
Type
article
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article

Inclusive Clinical Trials in Alzheimer’s Disease: A Latin American Perspective from LatAm FINGERS

Heather M. Snyder, Nilton Custodio, Lissette Duque, Lina Velilla et al.
Alzheimer s & Dementia
Ethics in Clinical Research
article

Inclusive Clinical Trials in Alzheimer’s Disease: A Latin American Perspective from LatAm FINGERS

Heather M. Snyder, Nilton Custodio, Lissette Duque, Lina Velilla, Francisco Lopera, María Isabel Cusicanqui, Carolina Delgado, Jorge M Leon‐Salas, Paulo Caramelli, Lucía Crivelli, Ana Charamelo, Cláudia Kimie Suemoto, Ricardo Nitríni, Ana Luisa Sosa, Rosa Maria Salinas‐Contreras, Ricardo Allegri, Ismael Luis Calandri, Gustavo Emilio Sevlever, Ivonne Z. Jiménez Velázquez, Miia Kivipelto, Daisy Acosta, Marı́a C. Carrillo, Monica Sanches Yassuda
article en

Abstract

Abstract Background The LatAm‐FINGERS trial marks a pioneering initiative as the first non‐pharmacological clinical trial encompassing participants from 12 Latin American countries, including Argentina, Brazil, Bolivia, Chile, Colombia, Costa Rica, Ecuador, Dominican Republic, Mexico, Peru, Puerto Rico, and Uruguay. This initiative represents a significant advancement in promoting inclusivity and diversity in clinical trial recruitment, particularly in underserved populations. Method The LatAm‐FINGERS trial is a multicenter randomized clinical trial evaluating a lifestyle intervention tailored for the Latin American population. Innovative and culturally sensitive recruitment methods were employed, utilizing social media, community outreach, and partnerships with religious groups to ensure inclusivity. The multidomain intervention includes diet, physical exercise, cognitive training, and health coaching and socialization. The intervention was delivered in teams of ten, with adherence strategies including moderated chat groups, dietary adaptations to local customs, shared cultural celebrations, recognition awards, personalized video tutorials, engagement calls, and motivational elements. These approaches facilitated participant retention and engagement despite socio‐economic challenges. Result Despite challenges such as transportation difficulties and risks of violence in certain regions, the trial effectively implemented prevention strategies across a diverse demographic spectrum. Recruitment for LatAm‐FINGERS began in December 2021. To date, 1186 participants (98.8%) have been randomized into the intervention group. The average age of participants is 69 (SD = 2.5) years, with an average educational level of 12.4 (SD = 3.4) years, and an MMSE score of 27.32 (SD = 1.68). The diversity of the Latin American population is evident in the self‐reported ethnicity data: 57.1% Mestizo, 27.7% White, 5.5% Mixed, 2% Black, 1% Native American, and 5.7% other. Conclusion Preliminary findings from LatAm‐FINGERS highlight the feasibility of conducting intervention trials within diverse populations. These findings underscore the importance of creating recruitment strategies that effectively engage underrepresented groups. This contributes significantly to global Alzheimer’s disease research efforts. The trial’s experience offers a valuable model for inclusive enrollment practices in Alzheimer’s disease and related dementia research, aligning with contemporary trends toward equitable and evidence‐based trial design.

Alzheimer s & DementiaVol. 20(S6)
Universidade Federal de Minas Gerais (BR), Alzheimer's Association (US), Universidade de São Paulo (BR), Universidad de la República de Uruguay (UY), University of Puerto Rico System (PR), Karolinska Institutet (SE), Universidad de Antioquia (CO), Kuopio University Hospital (FI), Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (AR), Universidad Nacional Pedro Henríquez Ureña (DO), Institute of Peruvian Studies (PE), Universidad Bíblica Latinoamericana (CR), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (BR), Instituto Nacional de Neurología y Neurocirugía (MX), Hospital de Clínicas (UY), Imperial College London (GB), University of Chile (CL)
Openalex Percentile: Top 62%
Ethics in Clinical Research
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