LatAm-FINGERS Initiative for Cognitive Change

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2027-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter study with blind evaluators, evaluating the feasibility of a lifestyle intervention over two years.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Multicenter study with blind evaluators, evaluating the feasibility of a lifestyle intervention over two years

Study Groups

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Systematic Lifestyle Intervention

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

Group Type EXPERIMENTAL

Systematic Lifestyle Intervention

Intervention Type BEHAVIORAL

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 Intervention

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

Group Type EXPERIMENTAL

Flexible Lifestyle Intervention

Intervention Type BEHAVIORAL

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

Interventions

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Systematic 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.

Intervention Type BEHAVIORAL

Flexible Lifestyle Intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Systematic Lifestyle Intervention (SLI) Flexible Lifestyle Intervention (FLI)

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Prof. Ricardo F. Allegri, MD., PhD.

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Role: STUDY_CHAIR

University of São Paulo School of Medicine, São Paulo, Brazil

Locations

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