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:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-24 @ 4:27 PM
NCT ID:
NCT02771366
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to participate in all aspects of the study;
* Not confined to a wheelchair;
* Evidence of cognitive aging based on Montreal Cognitive Assessment score less than or equal to 28, but greater than or equal to 23;
* Presence of elevated levels of systemic inflammation at screening (C-reactive protein levels \> 1.0)
* Able to swallow study product as directed.
Exclusion Criteria:
* Failure to give consent;
* Active treatment for cancer (\< 3 years);
* Stroke (\< 6 mo);
* Serious heart condition, peripheral vascular disease, coronary artery disease (myocardial infarction\<6 mo), Class III, IV Congestive Heart Failure;
* Dementia (e.g., Alzheimer's disease)
* Severe anemia (Hgb \< 8.0 g/dL);
* Any blood or bleeding disorders;
* Liver or renal disease;
* Diabetes;
* Severe osteoarthritis;
* Anticoagulant therapy (aspirin use is permitted);
* Parkinson's disease;
* Severe psychiatric disease or psychological disorder (e.g., severe depression, bi-polar disorder, schizophrenia) or current use of antipsychotics;
* Current use of anabolic medications (e.g., growth hormone or testosterone) or anticholinesterase inhibitor (i.e., Aricept);
* High amounts of physical activity (i.e., running, bicycling, etc.) \> 120 min/week;
* Excessive alcohol use (\>2 drinks per day);
* Use of tobacco products;
* Resting heart rate \> 120 bpm;
* History of significant head injury leading to cognitive impairments;
* Visual or hearing impairments that would interfere with testing;
* Allergies to papaya or foods with similar compounds (i.e., banana, avocado, kiwi, chestnuts, hazel nuts)
* Allergy to latex;
* Participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment;
* Center for Epidemiological Studies - Depression Scale (CES-D) Score \> 20.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
100 Years
Study:
NCT02771366
Study Brief:
Protocol Section:
NCT02771366