Agitation Associated With | Safety and Tolerability Study of Flexible Dosing 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 flexible dosing 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 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Agitation Associated With
Nervous System Diseases
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-34712Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks
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 (flexible dose range 0.5 to 2 mg)Titrate up from 0.25 mg/day brexpiprazole to 1 mg/day brexpiprazole. After achieving 1 mg/day target dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day.
Start Date: September 2013
Completed Date: March 2017
Phase: Phase 3
Primary Outcome: Change in the Cohen-Mansfield Agitation Inventory (CMAI) total score
Secondary Outcome: 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 Koheygi, MD
Collaborator: H. Lundbeck A/S