A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation
Condition: Agitation Associated With; Alzheimer's Disease; Alzheimer's Type; Mental Disorder; Nervous System Diseases
MeSH terms: Alzheimer Disease; Psychomotor Agitation; Nervous System Diseases; Mental Disorders
Intervention: Brexpiprazole, OPC-34712; Placebo Oral Tablet
Intervention description: Once-daily, tablets; Once-daily, tablets
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 433.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: OPC-34712; brexpiprazole; Dementia; Alzheimer's Disease; Cognitive Disorders; Agitation

Summary:

      To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with
      agitation associated with dementia of the Alzheimer's type.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants 55 to 90 years of age, inclusive, at the time of informed
             consent.

          -  Participants who are residing at their current location for at least 14 days before
             screening and are expected to remain at the same location for the duration of the
             trial.

          -  Participants with a diagnosis of probable Alzheimer's disease according to National
             Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's
             Disease and Related Disorders Association.

          -  Participants with a Mini-Mental State Exam score of 5 to 22, inclusive, at screening
             and baseline visits.

          -  Participants with onset of symptoms of agitation at least 2 weeks prior to the
             screening visit.

          -  Participants with a score of ≥ 4 on the agitation/aggression item of the
             Neuropsychiatric Inventory-Nursing Home at the screening and baseline visits.

          -  Participants who require pharmacotherapy for treatment of agitation per the
             investigator's judgment, after an evaluation for reversible factors (for example,
             pain, infection, polypharmacy) and a trial of nonpharmacological intervention.

          -  Participants must have a previous magnetic resonance imaging or computed tomography of
             the brain, which was performed after the onset of symptoms of dementia, with findings
             consistent with the diagnosis of Alzheimer's disease.

        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,
             pulmonary or cerebral embolism.

          -  Participants who currently have clinically significant neurological, hepatic, renal,
             metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal,
             or psychiatric disorders.

          -  Participants who have been diagnosed with an Axis I disorder (Diagnostic and
             Statistical Manual of Mental Disorders, 4th edition, text revision criteria)

          -  Participants with uncontrolled hypertension

          -  Participants with uncontrolled insulin-dependent diabetes mellitus

          -  Participants with epilepsy or a history of seizures

          -  Participants considered in poor general health based on the investigator's judgment.