Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT06492967
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
77 Years
Study:
NCT06492967
Study Brief:
Protocol Section:
NCT06492967