Valby,
The continuation of the study enables Lundbeck and Otsuka to further explore the efficacy of brexpiprazole to address the high medical need in patients suffering from agitation in Alzheimer's type dementia. Completion of the trial is expected in the first half of 2022.
About the study
Trial 331-14-213 (NCT03548584; Trial 213) was designed to assess the safety, tolerability and efficacy of brexpiprazole in the treatment of patients with agitation in Alzheimer's dementia. The trial consists of a continuous 12-week double-blind treatment period with a 30-day follow-up. The trial population is planned to include 330 male and female patients, aged 55-90 years, with a diagnosis of probable Alzheimer's disease.
The primary outcome is change in the Cohen-Mansfield Agitation Inventory (CMAI) Total score. The key secondary outcome measure is change in the Clinical Global Impression - Severity of Illness (CGI-S) score, as related to symptoms of agitation. Participating countries include
As agreed with the
About brexpiprazole
Rexulti/Rxulti (brexpiprazole) is approved as an adjunctive therapy for the treatment of adults with major depressive disorder and as a treatment for adults with schizophrenia in markets such as the
Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism of action for brexpiprazole in the adjunctive treatment of major depressive disorder or schizophrenia is not fully understood. However, the efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits high affinity (sub-nanomolar) for these receptors as well as for noradrenaline alpha1B/2C receptors.
Lundbeck contacts
Investors: | Media: |
Vice President, Investor Relations | Vice President, Corporate Communication |
PALO@lundbeck.com | JULZ@lundbeck.com |
+45 30 83 24 26 | +45 36 43 40 00 |
Otsuka contacts
In |
In |
Associate Director, PR | Leader, Pharmaceutical PR |
Robert.murphy@otsuka-us.com | Gilbert.jeffrey@otsuka.co.jp |
+1-609-249-7262 |
About
Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind.
Read more at www.lundbeck.com/global/about-us/progress-in-mind.
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About
In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.
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