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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT06423118
Eligibility Criteria:
Inclusion Criteria:
1. Sufficient knowledge of English to understand and provide informed consent
2. Competent to provide consent
3. Aged 55-85, Male and Female
4. ≥ 8 years of education
5. Capable of cooperating for the duration of the study procedures and assessments
6. No frank cognitive impairment or dementia
7. Sufficient (corrected) vision to participate in cognitive testing
8. Sufficient (corrected) hearing to participate in cognitive testing
Exclusion Criteria:
1. Cannot read and comprehend English language instructions
2. Major cardio- or cerebro-vascular event (heart attack, stroke, significant white matter changes)
3. Unstable diseases (e.g., pulmonary, endocrine disorder)
4. Active malignancy or infectious diseases
5. History of significant learning disability
6. Major psychiatric/neurologic/degenerative disorder, including a diagnosis of mild cognitive impairment or dementia
7. History of significant head trauma or recurrent concussions requiring hospitalization followed by persistent neurologic defaults or known structural brain abnormalities
8. Pain or sleep disorder that could interfere with cognitive testing
9. Major medical concerns that might interfere with cognitive testing
10. Recent history of substance/drug abuse
11. Known nickel allergy
12. Known cardiac implantable device
13. Known arrhythmias
14. Outside the included age range
15. Pregnant or breast feeding
16. Otherwise unable to use the ANNE sensors; for example, finger amputations.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT06423118
Study Brief:
Protocol Section:
NCT06423118