Latin American Lifestyle Intervention Initiative to Reduce the Risk and Prevent Cognitive Impairment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,065
- 试验地点
- 26
- 主要终点
- Implementation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Multicenter study with blind evaluators, evaluating the feasibility of a lifestyle intervention over two years
入排标准
- 年龄范围
- 60 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 60-77 years.
- •Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Risk Score >
- •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
排除标准
- •MMSE < 20
- •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.
研究组 & 干预措施
Systematic Lifestyle Intervention
Lifestyle modification program that involves participants completing structured activities that target diet, physical exercise, and intellectual and social stimulation.
干预措施: Systematic Lifestyle Intervention (Behavioral)
Flexible Lifestyle Intervention
Lifestyle modification program that is developed by the participant to meet his/her specific needs.
干预措施: Flexible Lifestyle Intervention (Behavioral)
结局指标
主要结局
Implementation
时间窗: Up to 2 years
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.
Reach
时间窗: Up to 2 years
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.
Maintenance
时间窗: Up to 2 years
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).
次要结局
- Global cognition(Up to 2 years)
研究者
Lucia Crivelli
PhD
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia