RecruitingNot ApplicableNCT06492967

LatAm-FINGERS Initiative for Cognitive Change

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


Sponsor

Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia

Enrollment

1,200 participants

Start Date

Sep 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 YearsMax Age: 77 Years

Inclusion Criteria5

  • 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 Criteria22

  • 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.

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.

BEHAVIORALFlexible Lifestyle Intervention

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


Locations(13)

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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NCT06492967


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