ClinicalTrials.gg
CompletedNCT06492967LatAmFINGERSUpdated May 4, 2026

LatAm-FINGERS Initiative for Cognitive Change

An interventional study of Systematic Lifestyle Intervention and Flexible Lifestyle Intervention in Alzheimer Disease, sponsored by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia. Completed at 13 sites in 12 countries. Open to participants aged 60 Years to 77 Years. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Oct 2021, registered May 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
1,065
Allocation
Randomized
Ages
60 Years to 77 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • Alzheimer Disease

Keywords

  • Alzheimer's Disease
  • Brain Diseases
  • Lifestyle
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's enrollment of 1,065 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 77 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: 60-77 years.
  • Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Risk Score > 6.
  • (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

Exclusion Criteria

  • \< 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 V (DSM V) criteria.
  • Severe cardiovascular disease, including heart failure, 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 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.
  • >40
  • Cerebral vascular disease in the last 2 years.
  • Insulin-dependent diabetes mellitus.
  • Pulmonary disease requiring oxygen and/or .
  • Renal disease defined as increased renal \<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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,065 participants (actual)

Study arms

  • Experimental
    Systematic Lifestyle Intervention

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

    Behavioral: Systematic Lifestyle Intervention

  • Experimental
    Flexible Lifestyle Intervention

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

    Behavioral: Flexible Lifestyle Intervention

Interventions

  • BehavioralSystematic Lifestyle Intervention

    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)

  • BehavioralFlexible Lifestyle Intervention

    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)

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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).

    Time frame: Up to 2 years

Secondary outcomes

  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.

    Time frame: Up to 2 years

07

Study locations

13 sites
  • 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
    Mexico City, Mexico
  • Instituto Peruano de Neurociencas
    Lima, Peru
  • Universidad de Puerto Rico
    San Juan, Puerto Rico
  • Clínica de la Memoria - Hospital Británico
    Montevideo, Uruguay
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References and documents

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 Jul 13:S0140-6736(26)01278-X. doi: 10.1016/S0140-6736(26)01278-X. Online ahead of print. PubMed 42442374 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06492967
Lead sponsor
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
Collaborators
Alzheimer's Association
Responsible party
Lucia Crivelli (PhD, Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia) — Principal investigator
First posted
Jul 9, 2024
Start date
Oct 27, 2021
Primary completion
Nov 7, 2025
Completion
Nov 7, 2025
Last update
May 4, 2026

Study contacts

Ricardo Francisco Allegri, MD, Ph.D
principal investigator · Fleni Neurological Institute, Buenos Aires, Argentina
Lucía Crivelli, Ph.D
principal investigator · Fleni Neurological Institute, Buenos Aires, Argentina
Gustavo Emilio Sevlever, MD, Ph.D
principal investigator · Fleni Neurological Institute, Buenos Aires, Argentina
María Isabel Cusicanqui, MD
principal investigator · Centro Neurológico Mente Activa, La Paz, Bolivia
Ricardo Nitrini, MD, Ph.D
principal investigator · University of São Paulo School of Medicine, São Paulo, Brazil
Paulo Caramelli, MD, Ph.D
principal investigator · Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
Carolina Delgado Derio, MD, MSc
principal investigator · Hospital Clínico Universidad de Chile, Santiago, Chile
Francisco Lopera, MD, Ph.D
principal investigator · Antioquia University, Colombia
Jorge Mario Leon-Salas, MD
principal investigator · GBHI, TCD. Hospital Clínica Bíblica, San José, Costa Rica
Lissette Duque-Peñailillo, MD
principal investigator · Neuromedicenter, Quito, Ecuador
Ana Luisa Sosa, MD, Ph.D
principal investigator · Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, México
Nilton Custodio, MD, Ph.D
principal investigator · Instituto Peruano de Neurociencias, Lima, Perú
Ivonne Z. Jiménez-Velázquez, MD
principal investigator · Universidad de Puerto Rico, San Juan, Puerto Rico
Daisy Acosta, MD, Ph.D
principal investigator · Universidad Nacional Pedro Henriquez Urena (UNPHU), Santo Domingo, Dominican Republic
Ana María Charamelo Baietti, Ph.D
principal investigator · Facultad de Medicina-Hospital de Clínicas, Universidad de la República, Montevideo, Uruguay
Ricardo Francisco Allegri, MD, Ph.D
study chair · Fleni Neurological Institute, Buenos Aires, Argentina
Paulo Caramelli, MD, Ph.D
study chair · Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
Francisco Lopera, MD, Ph.D
study chair · Antioquia University, Colombia
Ricardo Nitrini, MD, Ph.D
study chair · University of São Paulo School of Medicine, São Paulo, Brazil
Gustavo Emilio Sevlever, MD, Ph.D
study chair · Fleni Neurological Institute, Buenos Aires, Argentina
Ana Luisa Sosa, MD, Ph.D
study chair · Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, México
Ismael Calandri, MD
study chair · Fleni Neurological Institute, Buenos Aires, Argentina
Rosa María Salinas, MD, Ph.D
study chair · Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, México
Claudia Suemoto, MD, Ph.D
study chair · University of São Paulo Medical School, São Paulo, Brazil
Lina Marcela Velilla, Ph.D
study chair · Antioquia University, Colombia
Mônica Sanches Yassuda, Ph.D
study chair · University of São Paulo School of Medicine, São Paulo, Brazil
Lucía Crivelli, Ph.D
study chair · Fleni Neurological Institute, Buenos Aires, Argentina
Sonia Maria Dozzi Bruki, MD, Ph.D
study chair · University of São Paulo School of Medicine, São Paulo, Brazil

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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