A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
Condition: Agitation Associated With Alzheimer's Dementia; Alzheimer Dementia
MeSH terms: Dementia; Alzheimer Disease; Psychomotor Agitation
Intervention: Brexpiprazole; Placebo
Intervention description: Oral tablets; Oral tablets
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 345.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Agitation

Summary:

      This study compares the efficacy of 2 doses of brexpiprazole with placebo in participants
      with agitation associated with dementia of the Alzheimer's type.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with a diagnosis of probable Alzheimer's disease.

          -  Participants with a diagnosis of agitation

          -  Participants with a MMSE score of 5 to 22, inclusive, at screening and baseline
             visits.

          -  Participants with a previous MRI or CT scan of the brain, that was performed after the
             onset of symptoms of dementia, with findings consistent with a diagnosis of
             Alzheimer's disease.

          -  Participants who are residing at their current location for at least 28 days before
             screening and are expected to remain at the same location for the duration of the
             trial.

          -  Institutionalized participants with an identified caregiver who has sufficient contact
             (minimum of 2 hours per day for 4 days per week) to describe the participant's
             symptoms and has direct observation of the participant's behavior.
             Non-institutionalized participants may not be living alone and must have an identified
             caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week)
             to describe the participant's symptoms and has direct observation of the participant's
             behavior.

          -  Participants with onset of symptoms of agitation at least 2 weeks prior to screening
             visit.

          -  Participants will and able to discontinue all prohibited concomitant medications to
             meet protocol required washouts prior to and during the trial period.

        Exclusion Criteria:

          -  Participants with dementia or other memory impairment not due to Alzheimer's disease.

          -  Participants with a history of stroke, well-documented transient ischemic attack, or
             pulmonary or cerebral embolism.

          -  Participants who had an insufficient response, based on the investigator's judgment,
             to 2 or more previous antipsychotic medications.

          -  Participants who have been diagnosed with an Axis I disorder.

          -  Participants who currently have clinically significant neurological, hepatic, renal,
             metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal,
             or psychiatric disorders.

          -  Participants with uncontrolled hypertension or symptomatic hypotension, or orthostatic
             hypotension.

          -  Participants with diabetes mellitus (insulin-dependent and non-insulin-dependent) may
             be eligible for the trial if their condition is stable and well-controlled.