LatAm-FINGERS Initiative for Cognitive Change
NCT Number: NCT06492967
Acronym: LatAmFINGERS
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alzheimer Disease
Interventions: BEHAVIORAL: Systematic Lifestyle Intervention|BEHAVIORAL: Flexible Lifestyle Intervention
Sponsor: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
Collaborators: Alzheimer's Association
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-09-01
Completion Date: 2027-12-01
Locations: Fleni, Ciudad Autonoma de Buenos Aire, Argentina|Centro Neurológico Mente Activa, La Paz, Bolivia|Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil|University of Sao Paulo School of Medicine, São Paulo, Brazil|Hospital Clínico Universidad de Chile, Santiago, Chile|Antioquia University, Antioquia, Colombia|Hospital Clínica Bíblica, San José, Costa Rica|Universidad Nacional Pedro Henriquez Urena (UNPHU), Santo Domingo, Dominican Republic|Neuromedicenter - Cognitive Disorders Unit, Quito, Ecuador|Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, Ciudad de mexico, Mexico|Instituto Peruano de Neurociencas, Lima, Peru|Universidad de Puerto Rico, San Juan, Puerto Rico|Clínica de la Memoria - Hospital Británico, Montevideo, Uruguay

Summary:
Currently, 40% of global dementia cases can be prevented through lifestyle changes, with Latin America having a 56% potential reduction due to its high-risk factors. At the moment, there are no medications that halt the clinical expression of dementia.

LatAm-FINGERS, a multicenter study across 12 Latin American countries, aims to study the feasibility of an intervention modifying lifestyle in individuals aged 60 to 77 at risk of dementia. Success could influence public policy on clinical care for older adults.

Primary Outcome Measures: Reach, It refers to the effectiveness of recruiting the target population. It will be measured by the ratio of randomized participants versus the ratio of screen-failures., Up to 2 years|Implementation, Adherence rate of participants to the protocol in both arms. It will be measured through the percentage of attendance to group meetings, attendance to physical and cognitive training sessions, and completion of dietary records., Up to 2 years|Maintenance, It consists of each center's ability to sustain the intervention. It will be measured through the percentage of subjects who complete outcome measures at each trial event (baseline, 6, 12, 18, and 24 months)., Up to 2 years
Secondary Outcome Measures: Global cognition, Global cognitive function will be obtained from a composite score derived from subtest scores on the LatAm Neuropsychological Test Battery (LatAm-NTB) that includes: Free and Cued Selective Reminding Test, Logical Memory, Digit Span, Concept Shifting Test, Digit Symbol Substitution Test, Semantic and phonological fluency, Trial Making Test, Stroop Test.

Scores from each individual test will be converted to z-scores that typically range from -3 to 3, with higher scores reflecting better performance, and averaged to form a composite., Up to 2 years