A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
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This study compares the efficacy of 2 doses of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type.
Condition or disease
Agitation Associated With Alzheimer's DementiaAlzheimer Dementia
Drug: BrexpiprazoleOther: Placebo
This is a phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the efficacy, safety, and tolerability of brexpiprazole compared with placebo. The trial consists of a 12-week double-blind treatment period with a 30 day follow-up. The trial population will include male and female subjects between 55 and 90 years of age (inclusive) with a diagnosis of probable Alzheimer's disease, who are residing either in an institutionalized setting or in a non-institutionalized setting where the subject is not living alone. This trial will analyze data gathered from 330 subjects at multiple countries. An interim analysis will be conducted when a targeted sample of the first 255 subjects has completed or discontinued the trial. Subjects may also be eligible to enter an active extension trial.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Actual Study Start Date :
May 16, 2018
Estimated Primary Completion Date :
Estimated Study Completion Date :
Resource links provided by the National Library of Medicine
Cohen-Mansfield Agitation Inventory (CMAI) total score [ Time Frame: From baseline to week 12 visit ]
Change from baseline to Week 12; assesses frequency of agitated behaviors in elderly persons. The scale consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. Each of the agitated behaviors are scored 1 (never) to 7 (several times an hours), with the total scale score ranging from 29 to 203. The higher the value, the more frequent an agitated behavior has occurred.
Secondary Outcome Measures :
Clinical Global Impression Severity of Illness (CGI-S) score [ Time Frame: From baseline to week 12 visit ]
Change from baseline to week 12, as related to agitation. CGI-S will be used to rate the severity of agitation. Score ranges from 0 (not assessed) to 7 (among the most extremely ill subjects). The higher the value, the more severe the agitation.
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Layout table for eligibility information
Ages Eligible for Study:
55 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects with a diagnosis of probable Alzheimer's disease.
Subjects with a diagnosis of agitation
Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.
Subjects with a previous MRI or CT scan of the brain, that was performed after the onset of symptoms of dementia, with findings consistent with a diagnosis of Alzheimer's disease.
Subjects who are residing at their current location for at least 28 days before screening and are expected to remain at the same location for the duration of the trial.
Institutionalized subjects with an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject's symptoms and has direct observation of the subject's behavior. Non-institutionalized subjects may not be living alone and must have an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject's symptoms and has direct observation of the subject's behavior.
Subjects with onset of symptoms of agitation at least 2 weeks prior to screening visit.
Subjects will and able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period.
Subjects with dementia or other memory impairment not due to Alzheimer's disease.
Subjects with a history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.
Subjects who had an insufficient response, based on the investigator's judgment, to 2 or more previous antipsychotic medications.
Subjects who have been diagnosed with an Axis I disorder.
Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
Subjects with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension.
Subjects with diabetes mellitus (insulin-dependent and non-insulin-dependent) may be eligible for the trial if their condition is stable and well-controlled.