An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia

Inclusion criteria

• ✓. Individuals diagnosed with any form of dementia (i.e., probable Alzheimer's Disease; vascular dementia; mixed; frontotemporal dementia)
• ✓. Subjects who have met DSM-5 criteria for dementia (major neurocognitive disorder) who have instances of acute psychomotor agitation.
• ✓. History of psychomotor agitation (e.g., kick, bite, flailing) to the point that it impairs social activities, requires staffing, or medical intervention, or impairs ability for functional activities of daily living.
• ✓. Subjects are expected to exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject's usual behavior.
• ✓. Subjects who have a score of ≤16 on the Mini-Mental State Exam (MMSE).
• ✓. Subjects with a remote (\>5 years) history of stroke may be included, regardless of size/location.
• ✓. Subjects who read, understand, and provide written informed consent, or who have a legally authorized representative (LAR).
• ✓. Subjects who are deemed to be medically appropriate for study participation by the principal investigator.

Exclusion criteria