Feasibility of Passive Data Collection in Dementia Subjects With Agitation

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.