Treatment With Brexpiprazole Shows Positive Results in Patients with Alzheimer Dementia


Brexpiprazole is indicated as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia.

A phase 3 clinical trial of brexpiprazole showed positive results in the treatment of agitation in patients with Alzheimer dementia, with the analysis concluding that there is a statistically significant difference from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between brexpiprazole and placebo, according to a Lundbeck press release.

Brexpiprazole was approved in the United States on July 10, 2015, as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia. The efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at noradrenaline alpha 1B/2C receptors, serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors.

The CMAI is a caregiver-rated questionnaire that measures the frequency of manifestations of 29 agitated behaviors in elderly persons, such as pacing, restlessness, yelling, and hitting. Agitation is a common neuropsychiatric symptom of Alzheimer dementia and is reported in approximately 45% of patients with the disease. Agitation in Alzheimer dementia is hypothesized to be associated with underlying pathophysiological circuit level dysfunctions in noradrenergic, serotonergic, and dopaminergic neurotransmission.

Although the full study results are not yet available, there are more analyses of the data set ready to be conducted to determine the full potential of brexpiprazole in the treatment of agitation in patients with Alzheimer dementia, according to Lundbeck.

Trial 331-14-213 was designed to assess the safety, tolerability, and efficacy of 2 fixed doses of brexpiprazole (2 mg/day and 3 mg/day) in the treatment of patients with agitation in Alzheimer dementia. A continuous 12-week double-blind treatment period with a 30-day follow-up was conducted, with the randomized trial population including 345 male and female patients. The age range was between 55 and 90 years of age and each participant had a diagnosis of probable Alzheimer disease meeting the criteria of agitation as defined by the International Psychogeriatric Association.

There was a change in CMAI total score at week 12 for all patients administered brexpiprazole versus those treated with placebo. Further, there was a significant change in the Clinical Global Impression-Severity of Illness (CGI-S) score as related to symptoms of agitation. The study included both patients who were living at home and those living in institutionalized settings in Bulgaria, Hungary, Serbia, Slovakia, Spain, Ukraine, and the United States.

The improvements from baseline on the primary endpoint of CMAI for patients administered brexpiprazole or 2 mg/day or 3 mg/day were statistically greater than patients in the placebo cohort.

Brexpiprazole was generally well-tolerated and no new safety signals were observed. The only treatment-emergent adverse event with more than 5% incidence in patients administered brexpiprazole was headache, whereas somnolence, nasopharyngitis, dizziness, diarrhea, urinary tract infection, and asthenia occurred at an incidence of at least 2% in the brexpiprazole cohort.


Otsuka Pharmaceutical and Lundbeck announce positive results showing reduced agitation in patients with Alzheimer's dementia treated with brexpiprazole. Lundbeck. June 27, 2022. Accessed June 29, 2022.

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