LatAm-FINGERS Initiative for Cognitive Change

NCT06492967 | Completed

• 1 other identifier: SG-21-715176-LatAm-FINGERS
• Study Type: interventional
• Target: 1,065
• Locations: 11 countries
• Sites: 12

Brief 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer's Disease; Brain Diseases; Lifestyle

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Global cognition

  Up to 2 years

Study Arms (2)

Systematic Lifestyle Intervention

EXPERIMENTAL

Lifestyle modification program that involves participants completing structured activities that target diet, physical exercise, and intellectual and social stimulation.

Behavioral: Systematic Lifestyle Intervention

Flexible Lifestyle Intervention

EXPERIMENTAL

Lifestyle modification program that is developed by the participant to meet his/her specific needs.

Behavioral: Flexible Lifestyle Intervention

Interventions

Systematic Lifestyle Intervention BEHAVIORAL

Lifestyle intervention that involves providing participants with education, support, and tangible tools to assist them in developing and carrying out healthier lifestyle practices.

Also known as: Systematic Lifestyle Intervention (SLI)

Systematic Lifestyle Intervention

Flexible Lifestyle Intervention BEHAVIORAL

Lifestyle intervention that involves a structured program of diet, physical and cognitive exercise, and management of cardiometabolic risks.

Also known as: Flexible Lifestyle Intervention (FLI)

Flexible Lifestyle Intervention

Eligibility Criteria

• Age: 60 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 60-77 years.
• Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Risk Score \> 6.
• Mini-Mental State Examination (MMSE) z score between 0 and -1.5 OR
• CERAD Word List Learning Task (10 word x 3 repetitions) \< 0 z score OR
• CERAD (delayed word list recall) \< z score \< 0

You may not qualify if:

• MMSE \< 20
• Dementia
• Any medical condition that affects the participant's safety.
• Severe osteoarticular problems that preclude the implementation of the physical activity intervention outlined in the protocol, such as, for example: osteoarthrosis of the knee(s), coxofemoral, or other.
• Significant neurological disease, including dementia, cognitive impairment, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis or history of significant head injury with persistent neurological sequelae or structural brain abnormalities, major depressive disorder within the last 2 months, history of bipolar disorder or schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders V (DSM V) criteria.
• Severe cardiovascular disease, including heart failure, clinically significant aortic stenosis, history of uncontrolled acute myocardial infarction (AMI) or angina and Cardiac rhythm disorders: g3 conduction block, uncontrolled arrhythmia, alterations in Q wave, S waver and T wave segment or QT segment and auricular fibrillation (AF) of less than one year of evolution, venous thrombosis or pulmonary thromboembolism (PTE) of less than 6 months of evolution and any pathology that in clinical judgment compromises the intervention of physical activity.
• Body Mass Index \>40
• Cerebral vascular disease in the last 2 years.
• Insulin-dependent diabetes mellitus.
• Pulmonary disease requiring oxygen and/or steroids.
• Renal disease defined as increased renal glomerular filtration rate \<60ml/min/1.73mt2 or albumin excretion rate (AER) \> 30mg/24 hrs.
• Clinically significant laboratory abnormalities as judged by the investigator.
• History within the last 2 years of treatment for primary or recurrent malignant disease.
• History of hip fracture, knee replacement, or spinal surgery within the last 6 months.
• Being in cardiopulmonary rehabilitation.

Sponsors & Collaborators

• Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia: lead
• Alzheimer's Association: collaborator

Study Sites (13)

Fleni

Ciudad Autonoma de Buenos Aire, Argentina

Location

Centro Neurológico Mente Activa

La Paz, Bolivia

Location

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

University of Sao Paulo School of Medicine

São Paulo, Brazil

Location

Hospital Clínico Universidad de Chile

Santiago, Chile

Location

Antioquia University

Antioquia, Colombia

Location

Hospital Clínica Bíblica

San José, Costa Rica

Location

Universidad Nacional Pedro Henriquez Urena (UNPHU)

Santo Domingo, Dominican Republic

Location

Neuromedicenter - Cognitive Disorders Unit

Quito, Ecuador

Location

Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez

Mexico City, Mexico

Location

Instituto Peruano de Neurociencas

Lima, Peru

Location

Universidad de Puerto Rico

San Juan, Puerto Rico

Location

Clínica de la Memoria - Hospital Británico

Montevideo, Uruguay

Location

Related Publications (1)

• Crivelli L, Calandri IL, Suemoto CK, Salinas RM, Velilla LM, Yassuda MS, Caramelli P, Lopera F, Nitrini R, Sevlever GE, Sosa AL, Acosta D, Baietti AMC, Cusicanqui MI, Custodio N, De Simone SD, Derio CD, Duque-Penailillo L, Duran JC, Jimenez-Velazquez IZ, Leon-Salas JM, Bergamo Y, Clarens MF, Damian A, Demey I, Helou MB, Marquez C, Martin ME, Martin MDGM, Querze D, Surace EI, Acosta-Egea S, Aguirre-Salvador E, de Souza LC, Cancado GHDCP, Brucki SMD, Friedlaender CV, Gomes KB, Gutierrez M, Rios CL, Galindo JGM, Montesinos R, Nunez-Herrera A, Ospina-Henao S, Rodriguez G, Masson VR, Sanchez M, Schenk CE, Soto L, Barbosa MT, Tosatti JAG, Vicuna Y, Espeland M, Hakansson K, Kivipelto M, Baker L, Snyder H, Carrillo M, Allegri RF. Latin American Initiative for Lifestyle Intervention to Prevent Cognitive Decline (LatAm-FINGERS): Study design and harmonization. Alzheimers Dement. 2023 Sep;19(9):4046-4060. doi: 10.1002/alz.13101. Epub 2023 May 19.

  PMID: 37204054 BACKGROUND

Related Links

• Project summary.

MeSH Terms

Conditions

Alzheimer Disease; Brain Diseases

Condition Hierarchy (Ancestors)

Dementia; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ricardo Francisco Allegri, MD, Ph.D

  Fleni Neurological Institute, Buenos Aires, Argentina

  PRINCIPAL INVESTIGATOR

• Lucía Crivelli, Ph.D

  Fleni Neurological Institute, Buenos Aires, Argentina

  PRINCIPAL INVESTIGATOR

• Gustavo Emilio Sevlever, MD, Ph.D

  Fleni Neurological Institute, Buenos Aires, Argentina

  PRINCIPAL INVESTIGATOR

• María Isabel Cusicanqui, MD

  Centro Neurológico Mente Activa, La Paz, Bolivia

  PRINCIPAL INVESTIGATOR

• Ricardo Nitrini, MD, Ph.D

  University of São Paulo School of Medicine, São Paulo, Brazil

  PRINCIPAL INVESTIGATOR

• Paulo Caramelli, MD, Ph.D

  Universidade Federal de Minas Gerais, Belo Horizonte, Brazil

  PRINCIPAL INVESTIGATOR

• Carolina Delgado Derio, MD, MSc

  Hospital Clínico Universidad de Chile, Santiago, Chile

  PRINCIPAL INVESTIGATOR

• Francisco Lopera, MD, Ph.D

  Antioquia University, Colombia

  PRINCIPAL INVESTIGATOR

• Jorge Mario Leon-Salas, MD

  GBHI, TCD. Hospital Clínica Bíblica, San José, Costa Rica

  PRINCIPAL INVESTIGATOR

• Lissette Duque-Peñailillo, MD

  Neuromedicenter, Quito, Ecuador

  PRINCIPAL INVESTIGATOR

• Ana Luisa Sosa, MD, Ph.D

  Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, México

  PRINCIPAL INVESTIGATOR

• Nilton Custodio, MD, Ph.D

  Instituto Peruano de Neurociencias, Lima, Perú

  PRINCIPAL INVESTIGATOR

• Ivonne Z. Jiménez-Velázquez, MD

  Universidad de Puerto Rico, San Juan, Puerto Rico

  PRINCIPAL INVESTIGATOR

• Daisy Acosta, MD, Ph.D

  Universidad Nacional Pedro Henriquez Urena (UNPHU), Santo Domingo, Dominican Republic

  PRINCIPAL INVESTIGATOR

• Ana María Charamelo Baietti, Ph.D

  Facultad de Medicina-Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay

  PRINCIPAL INVESTIGATOR

• Ricardo Francisco Allegri, MD, Ph.D

  Fleni Neurological Institute, Buenos Aires, Argentina

  STUDY CHAIR

• Paulo Caramelli, MD, Ph.D

  Universidade Federal de Minas Gerais, Belo Horizonte, Brazil

  STUDY CHAIR

• Francisco Lopera, MD, Ph.D

  Antioquia University, Colombia

  STUDY CHAIR

• Ricardo Nitrini, MD, Ph.D

  University of São Paulo School of Medicine, São Paulo, Brazil

  STUDY CHAIR

• Gustavo Emilio Sevlever, MD, Ph.D

  Fleni Neurological Institute, Buenos Aires, Argentina

  STUDY CHAIR

• Ana Luisa Sosa, MD, Ph.D

  Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, México

  STUDY CHAIR

• Ismael Calandri, MD

  Fleni Neurological Institute, Buenos Aires, Argentina

  STUDY CHAIR

• Rosa María Salinas, MD, Ph.D

  Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, México

  STUDY CHAIR

• Claudia Suemoto, MD, Ph.D

  University of São Paulo Medical School, São Paulo, Brazil

  STUDY CHAIR

• Lina Marcela Velilla, Ph.D

  Antioquia University, Colombia

  STUDY CHAIR

• Mônica Sanches Yassuda, Ph.D

  University of São Paulo School of Medicine, São Paulo, Brazil

  STUDY CHAIR

• Lucía Crivelli, Ph.D

  Fleni Neurological Institute, Buenos Aires, Argentina

  STUDY CHAIR

• Sonia Maria Dozzi Bruki, MD, Ph.D

  University of São Paulo School of Medicine, São Paulo, Brazil

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Multicenter study with blind evaluators, evaluating the feasibility of a lifestyle intervention over two years
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Multicenter study with blind evaluators, evaluating the feasibility of a lifestyle intervention over two years.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: July 9, 2024
• Study Start: October 27, 2021
• Primary Completion: November 7, 2025
• Study Completion: November 7, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1); DO (1); CO (1); PE (1); PR (1); BR (2); AR (1); ME (1); UR (1); EC (1); CL (1)