A Trial to Evaluate the Safety Efficacy and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

  • End date
    Apr 1, 2022
  • participants needed
  • sponsor
    Otsuka Pharmaceutical Development & Commercialization, Inc.
Updated on 1 May 2021
mini-mental state examination
alzheimer's disease


This study compares the efficacy of 2 doses of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type.


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.

Condition Dementia, Alzheimer's Disease, Alzheimer Dementia, Agitaton Associated With Alzheimer's Dementia, Agitation Associated With Alzheimer's Dementia, alzheimer, dementia alzheimer's type
Treatment Placebo, Brexpiprazole
Clinical Study IdentifierNCT03548584
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Last Modified on1 May 2021


Yes No Not Sure

Inclusion Criteria

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

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, 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
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