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 @ 4:53 AM
Ignite Modification Date:
2025-12-25 @ 4:53 AM
NCT ID:
NCT03577418
Eligibility Criteria:
Community-dwelling persons 55 years or older with a primary diagnosis of MCI or mild to moderate dementia will be eligible (Montreal Cognitive Assessment Score, MoCA, \> 10).24,25 PLWD/CI must have an identified care partner: a family member or close friend who knows the person well with contact at least three times/week. Informed consent will be obtained; if PLWD/CI are not able to provide informed consent, healthcare proxies will be asked to provide informed consent, with assent provided by PLWD/CI. The study clinician (board-certified geriatric psychiatrist) will be available to participants if unstable NPS develop during the study period. Participants must be fluent in written and oral English. PLWD/CI who are not experiencing any NPS at baseline (i.e., NPI-Q score of zero at baseline) will be excluded. PLWD/CI living in long-term care environments (e.g., nursing home, assisted living facility) will be excluded. Persons with comorbid active primary psychiatric illness (e.g., major depressive or bipolar mood disorders, psychotic disorders) will be excluded. We will recruit 20 dyads comprising PLWD/CI and the care partner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT03577418
Study Brief:
Protocol Section:
NCT03577418