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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT04645134
Eligibility Criteria:
Inclusion Criteria:
* Ages 65-85 y (inclusive)
* Body mass index (BMI) of 20-35 kg/m2 (inclusive)
* Willing to have blood and data stored for future research use
Exclusion Criteria:
* History of clinically diagnosed diabetes (Type 1 or 2) or a fasting blood glucose \>126 mg/dL
* Diagnosed Alzheimer's disease, dementia, or related-brain diseases
* Chronic use of atypical antipsychotic or bipolar medications
* Initiation of novel pharmacotherapy agents (such as antidepressant, hypertension, or dyslipidemia) within the last 3 months
* Uncontrolled hypertension (blood pressure \>160 systolic or \>110 diastolic)
* Asthma that limits the ability to participate in moderate to vigorous physical activity or requiring systemic glucocorticoid administration
* Emphysema that limits the ability to participate in moderate to vigorous physical activity or requiring systemic glucocorticoid administration
* Current alcohol use exceeding 14 drinks per week in women, exceeding 21 drinks per week in men, having treatment for alcohol abuse in the last year, or having treatment for alcohol abuse more than 1 year ago (but with inability to refrain from alcohol in the past year)
* Use of illegal drugs or marijuana within 1-month of completing a Screening Visit; treatment for drug addiction in the 1-year or having treatment for drug addiction \>1-year ago, but with an inability to refrain from the drug of addiction in the 1-year
* Unwilling to abstain from illegal drugs and marijuana for the duration of the study
* Contraindication for MRI (e.g., metal objects, claustrophobia, etc.)
* Psychotic mental illness (e.g., schizophrenia, bipolar, on-and- off use of anti-psychotic medication)
* History of cardiovascular disease (or diseases of the heart, lungs, or blood) that limits participation in moderate to vigorous physical activity
* History of liver, blood, kidney, thyroid or other diseases that limits moderate to vigorous physical activity at the time of enrollment
* Cancer that limits moderate to vigorous physical activity
* Treatment with systemic immunosuppressant medication
* Taking adrenergic stimulants (e.g., amphetamine) or adrenergic blockers (e.g., Propanolol) that will alter metabolic rate
* Have plans to substantially alter their current level of physical activity over the next 1-month
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT04645134
Study Brief:
Protocol Section:
NCT04645134