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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT03736057
Eligibility Criteria:
Inclusion Criteria:
1. Score \<26 on the Alabama Brief Cognitive screen or \<24 on the Montreal Cognitive Assessment.
2. Have a caregiver/informant/family member who spends at least 10 hours per week with the affected person and who is willing to participate
3. Be rated by a caregiver/informant as scoring ≥9 on the Functional Activities Questionnaire, including at least one domain score of 3 (dependent).
4. Have BPSD sufficient for the treating clinician to begin or change psychotropic drugs, and of sufficiently mild severity that a delay of 5 days before changing the prescription would not be harmful to the patient.
Exclusion Criteria:
1. BPSD of sufficient severity or intensity that (in clinician's opinion) require immediate medication change or referral for emergency services
2. Lack of reliable informant with adequate exposure to patient and ability to communicate with study staff in English
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03736057
Study Brief:
Protocol Section:
NCT03736057