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Agitation Associated With | Safety and Tolerability Study of Two Fixed-doses of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Agitation Associated With research study

What is the primary objective of this study?

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

Who is eligible to participate?

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 a diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA. - 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 score of ≥ 4 on the agitation/aggression item of the NPI-NH at the screening and baseline visits. - Subjects who require pharmacotherapy for treatment of agitation per the investigator's judgment, after an evaluation for reversible factors (eg, pain, infection, polypharmacy) and a trial of nonpharmacological intervention. - 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 a history of stroke, well-documented transient ischemic attack, 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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Agitation Associated With

Alzheimer's Disease

Alzheimer's Type

Mental Disorder

Nervous System Diseases

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Brexpiprazole, OPC-34712Once-daily, tablets

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PlaceboMatching Placebo Once-Daily

brexpiprazole 1mgtitrate up from 0.25 mg/day brexpiprazole to 1 mg/day brexpiprazole

brexpiprazole 2mgtitrate up from 0.25 mg/day brexpiprazole to 2 mg/day brexpiprazole

Study Status

Completed

Start Date: July 2013

Completed Date: March 2017

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: The primary outcome is the change in the Cohen-Mansfield Agitation Inventory (CMAI) total score

Secondary Outcome: The secondary outcome is the change in the Clinical Global Impression-Severity of Illness (CGI-S) score, as related to symptoms of agitation

Study sponsors, principal investigator, and references

Principal Investigator: Eva Kohegyi, MD

Lead Sponsor:

Collaborator: H. Lundbeck A/S

More information:https://clinicaltrials.gov/show/NCT01862640

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