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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT04413851
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects 18 years and older.
* Subjects who have met DSM-5 criteria for Dementia (all cause)
* Subjects with a recent history of agitation in the past 6 months to a point that impairs social activities, requires staffing or medical intervention (kick, bite, flailing, etc.), impairs ability for functional activities of daily living, as disclosed by a caregiver or documented in the medical record.
* Subjects resident in a group home, nursing home, or assisted living are eligible to participate.
* Subjects who can read, understand and provide written informed consent or who have a Legally Acceptable Representative (LAR)
* Subjects who are willing and able to carry a smartphone and wear an activity tracker on their wrist or hand, alone or with the help of a caregiver.
* Subjects who, either alone or with a caregiver, are able to operate a smartphone and wrist or hand-worn activity tracker, alone or with the help of a caregiver.
* Subjects who are in good general health prior to study participation as determined by a detailed medical history, and in the opinion of the Principal Investigator.
* Subjects, who are able to ambulate without an assistive device, or with a single point cane.
Exclusion Criteria:
* Subjects who are unwilling or unable to carry a smartphone and wear an activity tracker on their wrist or hand.
* Subjects with serious or unstable medical illnesses. These include current hepatic (moderate-severe hepatic impairment), renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease, congestive heart failure), endocrinologic, neurologic or hematologic disease.
* Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04413851
Study Brief:
Protocol Section:
NCT04413851