An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia
Condition: Agitation; Dementia
MeSH terms: Dementia; Psychomotor Agitation
Intervention: BXCL501; BXCL501; Placebo film
Intervention description: Sublingual film containing 40 Micrograms BXCL501; Sublingual film containing 60 Micrograms BXCL501; Matching Sublingual Placebo film
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study will randomize subjects 1:1:1 to receive BXCL501 40 μg, BXCL501 60 μg, or matching placebo film
Masking: Double (Participant, Investigator)
Masking description: Double-Blind, Placebo controlled
Enrollment: 5.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      A randomized, double-blind, placebo-controlled parallel group 3-arm study assessing efficacy,
      safety, and tolerability of two doses BXCL501 in male and female geriatric residents (65
      years and older) with acute agitation associated with all forms of dementia (i.e., probably
      Alzheimer's Disease, vascular dementia; mixed; frontotemporal dementia) excluding
      Parkinson's-Related Dementia and Lewy Body Dementia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Individuals diagnosed with any form of dementia (i.e., probable Alzheimer's Disease;
             vascular dementia; mixed; frontotemporal dementia)

          2. Subjects who have met DSM-5 criteria for dementia (major neurocognitive disorder) who
             have instances of acute psychomotor agitation.

          3. 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.

          4. 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.

          5. Subjects who have a score of ≤16 on the Mini-Mental State Exam (MMSE).

          6. Subjects with a remote (>5 years) history of stroke may be included, regardless of
             size/location.

          7. Subjects who read, understand, and provide written informed consent, or who have a
             legally authorized representative (LAR).

          8. Subjects who are deemed to be medically appropriate for study participation by the
             principal investigator.

          9. 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.

         10. Subjects who have the capability to participate in the study and self-administer the
             investigational product.

         11. 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:

          1. Subjects who have dementia associated with Parkinson's disease and/or Lewy Body
             Disease are excluded.

          2. Subjects suffering from alcohol and/or substance abuse.

          3. Subjects with agitation caused by acute intoxication must be excluded.

          4. Subjects with significant risk of suicide or homicide per the investigator's
             assessment.

          5. 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.

          6. History of clinically significant syncope or syncopal attacks, orthostatic hypotension
             within the past 2 years.

          7. Subjects with laboratory or ECG abnormalities.

          8. Subjects with serious, unstable, or uncontrolled medical illnesses must be excluded.

          9. Subjects who have received an investigational drug within 30 days prior to Screening
             must be excluded.

         10. Subjects who are considered by the investigator, for any reason, to be an unsuitable
             candidate for receiving dexmedetomidine must be excluded.

         11. 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.