NCT06492967 · RECRUITING
LatAm-FINGERS Initiative for Cognitive Change
LatAm-FINGERS is testing two versions of a lifestyle program — one more structured, one more flexible — to see whether changing diet, exercise, and other daily habits can slow cognitive decline in older adults at elevated dementia risk across 12 Latin American countries. This is a Phase NA feasibility study, meaning researchers are first checking whether the program can actually be delivered at scale before drawing conclusions about effectiveness.
You may qualify if
- 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
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-07-09