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

The study will enroll at least 75 subjects to receive a single film consisting of BXCL501 40 μg dose, BXCL501 60 μg dose, or matching placebo film. Subjects must reside in a residential care facility and must require at least moderate assistance with activities of daily living (e.g., bathing, dressing, and toileting). The subject must be able to self-administer the film to participate in the study.

The effects of BXCL 501 on acute agitation will be assessed by the following scales: PEC, PAS, ACES, and CGI-I.

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.
• Subjects who are at their current location for at least 14 days before screening and plan to remain at the same location for the duration of the study.
• Subjects who have the capability to participate in the study and self-administer the investigational product.
• Subjects who are on a stable concomitant medications regimen for the treatment of any concurrent conditions for at least one month prior to the screening visit.

Exclusion criteria

• Subjects who have dementia associated with Parkinson's disease and/or Lewy Body Disease are excluded.
• Subjects suffering from alcohol and/or substance abuse.
• Subjects with agitation caused by acute intoxication must be excluded.
• Subjects with significant risk of suicide or homicide per the investigator's assessment.
• Subjects who have hydrocephalus, seizure disorder, or history of significant head trauma, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, or focal neurological findings, with a recent (1 year) large (non-microvascular) stroke who may be considered medically unstable or in recovery must be excluded.
• History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years.
• Subjects with laboratory or ECG abnormalities.
• Subjects with serious, unstable, or uncontrolled medical illnesses must be excluded.
• Subjects who have received an investigational drug within 30 days prior to Screening must be excluded.
• Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving dexmedetomidine must be excluded.
• Subjects whose agitation is attributed to pain or infection, delirium, concomitant medications, environmental conditions, or another psychiatric condition or medical condition as determined by the investigator.