Brexpiprazole is safe and effective for treating agitation in dementia related to Alzheimer’s disease


August 11, 2022

2 minute read


GrossbergGT, et al. Efficacy, safety, and tolerability of brexpiprazole for the treatment of agitation in Alzheimer’s dementia: a 12-week, randomized, double-blind, placebo-controlled trial. Presented at: Alzheimer’s Association International Conference; July 31-August. 4; San Diego.

Disclosures: Grossberg is employed by Saint Louis University. Luthman is employed by Lundbeck.

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SAN DIEGO – In older adult patients with dementia related to Alzheimer’s disease, treatment with brexpiprazole resulted in a greater reduction in agitation compared to placebo, while being safe and well tolerated.

“Agitation is a common clinical manifestation of Alzheimer’s dementia and is one of the most stressful aspects of care for patients affected by the disease,” George T. Grossberg, MD, professor of psychiatry at Saint Louis University School of Medicine, wrote in a presentation given at the Alzheimer’s Association International Conference.

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“However, currently there are no FDA-approved pharmacological treatments for agitation in this patient population.”

Following two previous clinical trials of brexpiprazole in this patient population, Grossberg and colleagues sought to confirm the efficacy, safety, and tolerability of brexpiprazole in agitated patients with Alzheimer’s dementia.

The trial was a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-arm study that included 345 patients aged 55 to 90 years, in care facilities or in community settings, had a diagnosis of probable Alzheimer’s disease. and meets the criteria for agitation as defined by the International Psychogeriatric Association. Participants were randomized on a 2:1 basis to receive either brexpiprazole or placebo; within the brexpiprazole group, participants were then randomized 1:2 to receive a fixed dose of 2 mg daily or 3 mg daily.

Stable basic drugs for the treatment of Alzheimer’s disease were authorized. The primary endpoint was the change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score, with the secondary endpoint change from baseline to week 12. 12 in the CGI-S score (Clinical Global Impression Severity of disease), in relation to agitation. . Safety was also assessed.

The results showed that the mean change from baseline to week 12 in the total CMAI score was statistically significantly greater in the brexpiprazole group compared to the placebo group. A statistically significant separation between the brexpiprazole and placebo groups was also observed for the key secondary endpoint of change in CGI-S score from baseline to week 12. Other than headache (6.6%), no other adverse events related to treatment only occurred with an incidence of 5% in the brexpiprazole cohort.

“We are extremely grateful to all the patients with Alzheimer’s dementia, their families and the researchers who participated in the trials and who contributed greatly to this research,” Johan Luthman, PhD, executive vice president and head of research and development at Lundbeck, said in a statement accompanying the study.

  • References:
  • Otsuka Pharmaceutical and Lundbeck present positive results showing reduced agitation in Alzheimer’s dementia patients treated with brexpiprazole at the 2022 Alzheimer’s Association International Conference. Published August 4, 2022. Accessed August 11, 2022.


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