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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT07232667
Eligibility Criteria:
Inclusion Criteria:
1. Currently living or receiving care in a stable environment for at least four weeks prior to enrollment:
* For community-based participants: must have resided at the same address for ≥4 weeks.
* For day-care participants: must have attended activities at the same dementia or elderly day-care center for ≥4 weeks.
2. Able and willing to participate in the study procedures.
3. Informed consent must be obtained before participation.
* If the participant's cognitive function has declined to a level that prevents self-consent, written consent will be obtained from a legally authorized representative or primary caregiver.
Exclusion Criteria:
1. Unstable physical or psychological condition that makes participation unsafe, as determined by a clinical investigator - e.g., acute delirium or current respiratory infection (including COVID-19).
2. Any known allergy or skin sensitivity to the materials used in the Geneactiv actigraphy device or iCue sensor pad.
3. Any other medical, neurological, or behavioral condition deemed unsuitable for participation by the study physician.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT07232667
Study Brief:
Protocol Section:
NCT07232667