Lifestyle changes to prevent dementia in older adults in Latin America
Latin American Lifestyle Intervention Initiative to Reduce the Risk and Prevent Cognitive Impairment.
This study is testing whether a lifestyle program that includes exercise, a healthy diet, and social activities can help older adults in Latin America at risk of dementia improve their brain health over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 60 Years to 77 Years |
| Sex | All |
| Sponsor | Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia Academic / other |
| Locations | 13 sites (Ciudad Autonoma de Buenos Aire and 12 other locations) |
| Trial ID | NCT06492967 on ClinicalTrials.gov |
What this trial studies
The LatAm-FINGERS initiative is a multicenter intervention aimed at preventing cognitive decline in individuals aged 60 to 77 at risk of dementia across 12 Latin American countries. Participants will be randomly assigned to either a systematic lifestyle intervention group, which includes physical and cognitive training, a Mediterranean-style diet, socialization, and regular health check-ups, or a control group receiving standard health advice. The study seeks to determine the feasibility of this intervention and its potential impact on cognitive improvement over a two-year period. Given the high prevalence of dementia risk factors in the region, this initiative could inform public health policies for older adults.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 60 to 77 with cardiovascular risk factors and mild cognitive impairment.
Not a fit: Patients with diagnosed dementia or significant neurological diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of dementia through lifestyle modifications in at-risk populations.
How similar studies have performed: Other studies have shown success with lifestyle interventions in dementia prevention, making this approach promising yet tailored to the specific needs of the Latin American population.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ciudad Autonoma de Buenos Aire and 12 other locations
- Fleni — Ciudad Autonoma de Buenos Aire, Argentina (Active_not_recruiting)
- Centro Neurológico Mente Activa — La Paz, Bolivia (Active_not_recruiting)
- Universidade Federal de Minas Gerais — Belo Horizonte, Minas Gerais, Brazil (Active_not_recruiting)
- University of Sao Paulo School of Medicine — São Paulo, Brazil (Active_not_recruiting)
- Hospital Clínico Universidad de Chile — Santiago, Chile (Active_not_recruiting)
- Antioquia University — Antioquia, Colombia (Active_not_recruiting)
- Hospital Clínica Bíblica — San José, Costa Rica (Active_not_recruiting)
- Universidad Nacional Pedro Henriquez Urena (UNPHU) — Santo Domingo, Dominican Republic (Active_not_recruiting)
- Neuromedicenter - Cognitive Disorders Unit — Quito, Ecuador (Active_not_recruiting)
- Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez — Ciudad de mexico, Mexico (Active_not_recruiting)
- Instituto Peruano de Neurociencas — Lima, Peru (Active_not_recruiting)
- Universidad de Puerto Rico — San Juan, Puerto Rico (Recruiting)
- Clínica de la Memoria - Hospital Británico — Montevideo, Uruguay (Active_not_recruiting)
Study contacts
- Principal investigator: Ricardo Francisco Allegri, MD, Ph.D — Fleni Neurological Institute, Buenos Aires, Argentina
- Study coordinator: Lucía Crivelli, Ph.D
- Email: lcrivelli@fleni.org.ar
- Phone: +54 9 1141933274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.