Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Condition: Agitation Associated With; Alzheimer's Disease; Alzheimer's Type; Mental Disorder; Nervous System Diseases
MeSH terms: Alzheimer Disease; Dementia; Psychomotor Agitation; Nervous System Diseases; Mental Disorders
Intervention: Brexpiprazole, OPC-34712
Intervention description: Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks
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: 270.0
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 flexible dosing of brexpiprazole with placebo in subjects with
      agitation associated with dementia of the Alzheimer's type
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects 55 to 90 years of age, inclusive, at the time of informed
             consent.

          -  Subjects 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.

          -  Subjects with diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA
             criteria.

          -  Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.

          -  Subjects with onset of symptoms of agitation at least 2 weeks prior to the screening
             visit.

          -  Subjects with a total score greater than or equal to 4 on the agitation aggression
             item of the NPI-NH or NPI/NPI-NH at the screening and baseline visits.

          -  Subjects who require pharmacotherapy for the treatment of agitation per the
             investigator's judgement, after an evaluation of reversible factors (eg, pain,
             infection, polypharmacy) and a trial of nonpharmacological interventions.

          -  Subjects must have a previous MRI or CT scan 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:

          -  Subjects with dementia or other memory impairment not due to Alzheimer's disease.

          -  Subjects with history of stroke, well-documented transient ischemic attack, or
             pulmonary or cerebral embolism.

          -  Subjects who currently have clinically significant neurological, hepatic, renal,
             metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal,
             or psychiatric disorders.

          -  Subjects who have been diagnosed with an Axis I disorder (DSM-IV-TR criteria).

          -  Subjects with uncontrolled hypertension.

          -  Subjects with uncontrolled insulin-dependent diabetes mellitus (IDDM)

          -  Subjects with epilepsy or a history of seizures.

          -  Subjects considered in poor general health based on the investigator's judgment.