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Alzheimer DiseaseLatAmFINGERSNCT06492967

LatAm-FINGERS Initiative for Cognitive Change

A study testing Systematic Lifestyle Intervention and Flexible Lifestyle Intervention in people with Alzheimer Disease, run by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia at 13 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 77 years
Conditions the study is for
Alzheimer Disease
What is being tested?
Systematic Lifestyle Intervention and Flexible Lifestyle Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,065 participants
Where
13 sitesin 12 countries
Study dates
27 Oct 2021to 7 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 77 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

13 sites in 12 countries.

13 sites in 12 countries

Brazil2 sites
  • Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais

  • University of Sao Paulo School of Medicine

    São Paulo

Other trials in Brazil

Argentina1 site
  • Fleni

    Ciudad Autonoma de Buenos Aire

Other trials in Argentina

Bolivia1 site
  • Centro Neurológico Mente Activa

    La Paz

Other trials in Bolivia

Chile1 site
  • Hospital Clínico Universidad de Chile

    Santiago

Other trials in Chile

Colombia1 site
  • Antioquia University

    Antioquia

Other trials in Colombia

Costa Rica1 site
  • Hospital Clínica Bíblica

    San José

Other trials in Costa Rica

Dominican Republic1 site
  • Universidad Nacional Pedro Henriquez Urena (UNPHU)

    Santo Domingo

Other trials in Dominican Republic

Ecuador1 site
  • Neuromedicenter - Cognitive Disorders Unit

    Quito

Other trials in Ecuador

Mexico1 site
  • Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez

    Mexico City

Other trials in Mexico

Peru1 site
  • Instituto Peruano de Neurociencas

    Lima

Other trials in Peru

Puerto Rico1 site
  • Universidad de Puerto Rico

    San Juan

Other trials in Puerto Rico

Uruguay1 site
  • Clínica de la Memoria - Hospital Británico

    Montevideo

Other trials in Uruguay

About this study

Official title: Latin American Lifestyle Intervention Initiative to Reduce the Risk and Prevent Cognitive Impairment.

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.

Read the 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.

Being tested
Systematic Lifestyle Intervention, Flexible Lifestyle Intervention
Keywords
Alzheimer's Disease, Brain Diseases, Lifestyle
Medical subject headings
Alzheimer Disease, Brain Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Systematic Lifestyle InterventionBehavioural

    Also called Systematic Lifestyle Intervention (SLI)

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

  • Flexible Lifestyle InterventionBehavioural

    Also called Flexible Lifestyle Intervention (FLI)

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

Study groups in NCT06492967
Study groupRoleWhat they receive
Systematic Lifestyle InterventionExperimentalLifestyle modification program that involves participants completing structured activities that target diet, physical exercise, and intellectual and social stimulation.
Receives: Behavioral: Systematic Lifestyle Intervention
Flexible Lifestyle InterventionExperimentalLifestyle modification program that is developed by the participant to meet his/her specific needs.
Receives: Behavioral: Flexible Lifestyle Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

  3. 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).

    Measured: Up to 2 years

Secondary outcomes (1)
  1. 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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start27 Oct 2021
  3. Primary completion7 Nov 2025
  4. Study completion7 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter study with blind evaluators, evaluating the feasibility of a lifestyle intervention over two years.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,065 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06492967
Sponsor's protocol ID
SG-21-715176-LatAm-FINGERS
Acronym
LatAmFINGERS
Status last verified
Apr 2026
First submitted
30 May 2023
Last updated
4 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37204054
  • Crivelli L, Suemoto CK, Sosa AL, Lopera F, Aguillon D, Allegri RF, Nitrini R, Calandri IL, Velilla-Jimenez L, Yassuda MS, Acosta-Baena N, Salinas RM, Charamelo A, Derio CD, Acosta DM, Leon-Salas JM, Duque-Penailillo L, Cusicanqui MI, Custodio N, Anchia-Alfaro A, Nunez-Herrera A, Rubens A, Leites A, Vigil-Martinez A, Damian A, Flores-Blanco BM, Custodio B, Laforcada C, Marquez C, Friedlaender CV, Espinoza-Cruz CG, Canadas C, Peixoto C, Munoz DH, Slezak DF, Felix E, Aguirre-Salvador E, Surace EI, Mariani F, De La Torre GR, Verastegui G, Keller G, Peixoto GH, Morilla HA, Jimenez-Velazquez IZ, More JY, Rodriguez JF, Tosatti JAG, de Faria Rocha JV, Saldarriaga-Hernandez J, Huilca JC, Garcia-Molina JT, Martinez-Galindo JG, Duran JC, Rodriguez JG, Gomes KB, Cesar-Freitas KG, Aguero K, Mora-Villalobos L, Asprilla LO, de Souza LC, Soto L, Cortabarria L, Baldeon L, Carreira LL, Marin-Buitrago L, Moreno MC, Barbosa MT, Torheim M, Magalhaes MAZ, da Graca Morais Martin M, Martin ME, Torres MF, Menendez M, Hernandez MA, Granizo MS, Gutierrez M, Corvalan N, Mora PJ, Peguero P, Ramirez-Santos R, Fernandez RS, Montesinos R, Ospina-Henao S, Montes SY, Santero S, Brucki SMD, Josephy-Hernandez S, Vazquez TC, Bergamo Y, Bocanegra Y, Munoz YA, Vicuna Y, Lora ZDC, Kivipelto M, Raman R, Espeland MA, Baker LD, Snyder HM, Sevlever GE, Carrillo MC, Caramelli P; LatAm-FINGERS Study Group. Multidomain lifestyle intervention for the prevention of cognitive decline in at-risk older adults in Latin America (LatAm-FINGERS): a single-blind, multicentre, randomised controlled trial. Lancet. 2026 Aug 1;408(10553):417-429. doi: 10.1016/S0140-6736(26)01278-X. Epub 2026 Jul 13.

    PubMed 42442374

Questions about this trial

What is this clinical trial studying?

A study testing Systematic Lifestyle Intervention and Flexible Lifestyle Intervention in people with Alzheimer Disease, run by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia at 13 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Brazil, Argentina, Bolivia, Chile, Colombia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reach (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06492967, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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