Status:
RECRUITING
LatAm-FINGERS Initiative for Cognitive Change
Lead Sponsor:
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia
Collaborating Sponsors:
Alzheimer's Association
Conditions:
Alzheimer Disease
Eligibility:
All Genders
60-77 years
Phase:
NA
Brief 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 medica...
Detailed Description
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 fo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT06492967
Start Date
September 1 2021
End Date
December 1 2027
Last Update
July 9 2024
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Fleni
Ciudad Autonoma de Buenos Aire, Argentina
2
Centro Neurológico Mente Activa
La Paz, Bolivia
3
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
4
University of Sao Paulo School of Medicine
São Paulo, Brazil