Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: H. Lundbeck A/S
• Treatments: Brexpiprazole

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.