Rexulti Shows Efficacy Treating Agitation Associated With Dementia Due to Alzheimer Disease


Rexulti was found to be a well-tolerated treatment for the debilitating symptoms of agitation associated with dementia due to Alzheimer’s disease.

Brexpiprazole (Rexulti) produced statistically significant and clinically meaningful improvements among adults experiencing agitation associated with dementia due to Alzheimer disease, according to a recent study.1

Image credit: Feng Yu |

Image credit: Feng Yu |

Patients enrolled in the placebo-controlled, phase 3 Study 213 (NCT03548584), published in JAMA Neurology, were administered either 2 mg or 3 mg daily of Rexulti or a placebo, showing significantly improved symptoms following 12 weeks of treatment across both dosage strengths vs. placebo.

“One of the most challenging aspects of caring for someone with Alzheimer’s dementia, whether it be a healthcare provider or loved one, is when they develop agitation symptoms that become increasingly difficult to manage alone,” said senior author George T. Grossberg, MD, Department of Psychiatry and Behavioral Neuroscience at Saint Louis University School of Medicine, in a press release.1 “The findings of this study provide evidence that brexpiprazole meets the needs of patients and their caregivers and is an efficacious, well-tolerated treatment for the often-debilitating symptoms of agitation associated with dementia due to Alzheimer’s disease.”

Earlier this year, Rexulti was approved by the FDA as the first treatment indicated for agitation associated with dementia due to Alzheimer disease.2

Alzheimer disease affects more than 6.5 million patients living with the condition in the United States. The disease is the leading cause of dementia, a debilitating neurological condition characterized by the decline of one or more cognitive domains in the brain.

Dementia may lead to psychological and behavioral disturbances, the most common of which being agitation. It is a common neuropsychiatric symptom that has been reported in approximately half of all patients with Alzheimer-related dementia, which has been observed in 45% to 61% of patients with dementia in community settings, as well as 53% in long-term care settings.1

In clinical trials, Rexulti was found to improve all three classifications of agitation symptoms: aggressive behavior, physically nonaggressive behavior, and verbally agitated behavior. Study 213 showed positive efficacy and acceptable tolerability for Rexulti vs. placebo.

Among patients randomly assigned to receive either a 2 or 3 mg daily dose of Rexulti, symptoms of agitation were found to significantly improve following 12 weeks of treatment compared to patients administered the placebo across six efficacy endpoints.

“Agitation associated with dementia due to Alzheimer’s disease can be very challenging and emotionally distressing for patients and family members caring for them,” said John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka.1 “With the publication of the complete Study 213 data, the evidence of brexpiprazole as an effective, well-tolerated treatment for this indication will help clinicians, families and caregivers make informed decisions about what is best for their patient or loved one who lives with this complex condition.”

Rexulti also produced a 22.6-point decrease in mean CMAI total scores vs. placebo, which led to a 17.6-point decrease in mean CMAI scores. Rexulti showed a clinical safety profile that is consistent with the known profile for this indication. Approximately 86.8% of patients completed the trial in the treatment cohort vs. 88.9% in the placebo cohort. From baseline to week 12, researchers did not observe worsening of cognitive functions. The most common adverse events included weight gain, akathisia, headache, somnolence, anxiety, and restlessness.

“The JAMA Neurology publication of Study 213 for brexpiprazole in the management of agitation associated with dementia due to Alzheimer’s disease further validates the clinical rigor of this pivotal Phase 3 trial within this patient population,” said Johan Luthman, executive vice president, Lundbeck Research & Development. “We greatly appreciate the efforts of those clinicians, patients, and their families that participated in this important clinical trial.”


1. JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease. News release. Lundbeck. November 6, 2023. Accessed November 7, 2023.

2. FDA. FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease. News Release. May 11, 2023. Accessed on May 1, 2023.

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