Clinical trial NCT06492967: LatAm-FINGERS Initiative for Cognitive Change
Official title: Latin American Lifestyle Intervention Initiative to Reduce the Risk and Prevent Cognitive Impairment.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer's Disease
Brain Diseases
Lifestyle
Lead sponsor: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2024-07-09
Enrollment: 1200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter study with blind evaluators, evaluating the feasibility of a lifestyle intervention over two years.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Today we know that 40% of dementia cases worldwide can be prevented through lifestyle modification. If we look at Latin America, this number is 56%. Latin America is a region with high-risk factors for dementia due to weakened socioeconomic infrastructure, an impoverished healthcare system, and low average education levels in the region. Additionally, we know that cardiovascular health is an important factor in the development of dementia.

Under this scenario, LatAm-FINGERS is a multicenter study designed to prevent memory decline through lifestyle modification in people aged 60 to 77 at risk of dementia. Twelve Latin American countries are participating (Argentina, Bolivia, Brazil, Chile, Colombia, Dominican Republic, Mexico, Puerto Rico, Uruguay, Costa Rica, Ecuador, and Peru), with 100 individuals per center. These individuals are randomly assigned to two groups: (1) a group making systematic lifestyle changes (physical and cognitive training, implementation of the Mediterranean-dietary approach to stop hypertension (DASH) Intervention for Neurodegenerative Delay (MIND) diet, socialization, and regular health check-ups) and (2) a group receiving regular health advice.

The main objective of LatAm-FINGERS is to determine if this intervention is feasible in Latin America. Secondarily, we want to test if this lifestyle change can lead to improvements in participants' cognition over time (2 years).

If successful, the results of this study will have large-scale implications for public policy regarding the standard of clinical care and prescriptive practices for a fast-growing and vulnerable population of older adults.

LatAm-FINGERS is based on the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), which demonstrated that lifestyle modification promotes positive changes in memory and attention. Additionally, our study is aligned with the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER), which is conducting a similar intervention in the United States.

This project is fully funded by the Alzheimer's Association.

Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria

* 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.
* History of bariatric surgery.
* Cardiac surgery in the last year.
* Severe sensory loss or loss of communication skills.
* No schooling.
* Use of psychoactive medications within the past 3 months, including tricyclic antidepressants, antipsychotics, psychotropic mood-stabilizing agents (e.g., lithium salts), psychostimulants, opioid analgesics, antiparkinsonian medications, anticonvulsant medications (except gabapentin and pregabalin for non-convulsant indications), systemic corticosteroids, or medications with significant central anticholinergic activity; in the absence of major depression, stable doses of selective serotonin reuptake inhibitors or serotonin and norepinephrine reuptake inhibitors are permitted.
* Active participation in another intervention study.
* History of alcoholism or substance abuse in the last 2 years, according to DSM V criteria.

Primary outcomes:
measure: Reach
timeFrame: Up to 2 years
measure: Implementation
timeFrame: Up to 2 years
measure: Maintenance
timeFrame: Up to 2 years
Secondary outcomes:
measure: Global cognition
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Fleni
city: La Paz
country: Bolivia
facility: Centro Neurológico Mente Activa
city: Belo Horizonte
country: Brazil
facility: Universidade Federal de Minas Gerais
state: Minas Gerais
city: São Paulo
country: Brazil
facility: University of Sao Paulo School of Medicine
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
city: Antioquia
country: Colombia
facility: Antioquia University
city: San José
country: Costa Rica
facility: Hospital Clínica Bíblica
city: Santo Domingo
country: Dominican Republic
facility: Universidad Nacional Pedro Henriquez Urena (UNPHU)
city: Quito
country: Ecuador
facility: Neuromedicenter - Cognitive Disorders Unit
city: Ciudad de mexico
country: Mexico
facility: Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez
city: Lima
country: Peru
facility: Instituto Peruano de Neurociencas
city: San Juan
country: Puerto Rico
facility: Universidad de Puerto Rico
city: Montevideo
country: Uruguay
facility: Clínica de la Memoria - Hospital Británico
Study officials:
affiliation: Fleni Neurological Institute, Buenos Aires, Argentina
name: Ricardo Francisco Allegri, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Fleni Neurological Institute, Buenos Aires, Argentina
name: Lucía Crivelli, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Fleni Neurological Institute, Buenos Aires, Argentina
name: Gustavo Emilio Sevlever, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Neurológico Mente Activa, La Paz, Bolivia
name: María Isabel Cusicanqui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of São Paulo School of Medicine, São Paulo, Brazil
name: Ricardo Nitrini, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
name: Paulo Caramelli, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universidad de Chile, Santiago, Chile
name: Carolina Delgado Derio, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Antioquia University, Colombia
name: Francisco Lopera, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: GBHI, TCD. Hospital Clínica Bíblica, San José, Costa Rica
name: Jorge Mario Leon-Salas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neuromedicenter, Quito, Ecuador
name: Lissette Duque-Peñailillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, México
name: Ana Luisa Sosa, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Peruano de Neurociencias, Lima, Perú
name: Nilton Custodio, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Puerto Rico, San Juan, Puerto Rico
name: Ivonne Z. Jiménez-Velázquez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Nacional Pedro Henriquez Urena (UNPHU), Santo Domingo, Dominican Republic
name: Daisy Acosta, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Facultad de Medicina-Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay
name: Ana María Charamelo Baietti, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Fleni Neurological Institute, Buenos Aires, Argentina
name: Ricardo Francisco Allegri, MD, Ph.D
role: STUDY_CHAIR
affiliation: Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
name: Paulo Caramelli, MD, Ph.D
role: STUDY_CHAIR
affiliation: Antioquia University, Colombia
name: Francisco Lopera, MD, Ph.D
role: STUDY_CHAIR
affiliation: University of São Paulo School of Medicine, São Paulo, Brazil
name: Ricardo Nitrini, MD, Ph.D
role: STUDY_CHAIR
affiliation: Fleni Neurological Institute, Buenos Aires, Argentina
name: Gustavo Emilio Sevlever, MD, Ph.D
role: STUDY_CHAIR
affiliation: Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, México
name: Ana Luisa Sosa, MD, Ph.D
role: STUDY_CHAIR
affiliation: Fleni Neurological Institute, Buenos Aires, Argentina
name: Ismael Calandri, MD
role: STUDY_CHAIR
affiliation: Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, México
name: Rosa María Salinas, MD, Ph.D
role: STUDY_CHAIR
affiliation: University of São Paulo Medical School, São Paulo, Brazil
name: Claudia Suemoto, MD, Ph.D
role: STUDY_CHAIR
affiliation: Antioquia University, Colombia
name: Lina Marcela Velilla, Ph.D
role: STUDY_CHAIR
affiliation: University of São Paulo School of Medicine, São Paulo, Brazil
name: Mônica Sanches Yassuda, Ph.D
role: STUDY_CHAIR
affiliation: Fleni Neurological Institute, Buenos Aires, Argentina
name: Lucía Crivelli, Ph.D
role: STUDY_CHAIR
affiliation: University of São Paulo School of Medicine, São Paulo, Brazil
name: Sonia Maria Dozzi Bruki, MD, Ph.D
role: STUDY_CHAIR
References:
citation: 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.