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Abstract Details

Safety, Tolerability, and Efficacy of Brexpiprazole for the Treatment of Agitation Associated with Dementia Due to Alzheimer’s Disease: A 12-week Extension Trial
Aging, Dementia, Cognitive, and Behavioral Neurology
P11 - Poster Session 11 (5:30 PM-6:30 PM)
9-011
Agitation symptoms are common in AD, and are among the most challenging aspects of care. Brexpiprazole is FDA-approved for the treatment of agitation associated with dementia due to AD, making it the first approved medication for this indication in the US.
To assess the long-term safety, tolerability, and efficacy of brexpiprazole in patients with agitation associated with dementia due to Alzheimer’s disease (AD).
Study 182 was a 12-week, multicenter, single-arm brexpiprazole extension trial (NCT03594123), which enrolled patients who completed a 12-week, placebo-controlled trial of brexpiprazole 2 or 3 mg/day in patients with agitation associated with dementia due to AD (NCT03548584 [Study 213]). In Study 182, all patients received brexpiprazole 2 or 3 mg/day; dosing was blinded. Assessments of long-term safety and tolerability (primary objective) included treatment-emergent adverse events (TEAEs), suicidality, and body weight. Both studies evaluated efficacy using the Cohen-Mansfield Agitation Inventory (CMAI) and Clinical Global Impression − Severity (CGI-S) as related to agitation.
A total of 259 patients entered Study 182 (prior brexpiprazole, n=163; prior placebo, n=96). The overall incidence of TEAEs was 25.9% (prior brexpiprazole, 25.2%; prior placebo, 27.1%); 4.6% of patients discontinued due to adverse events. TEAEs with an overall incidence ≥2% were headache (3.5%) and fall (2.3%). There were no deaths in Study 182, and no reports of suicidal behavior/ideation. The mean (standard deviation) change in body weight from Study 182 baseline to Week 12 was 0.2 (5.6) kg. In Study 213, brexpiprazole demonstrated greater improvement (p<0.01) versus placebo in CMAI Total and CGI-S scores at Week 12. In Study 182, continued improvements in CMAI Total and CGI-S scores were observed.
In patients with agitation associated with dementia due to AD, brexpiprazole 2 or 3 mg/day was well-tolerated and efficacious throughout up to 24 weeks of treatment.
Authors/Disclosures

PRESENTER
No disclosure on file
George Grossberg, MD (St Louis University School of Medicine Department of Neurology & Psychiatry) Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Acadia. Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BioXcel. Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Karuna. Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Otsuka. The institution of Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Anavex. The institution of Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EryDel. The institution of Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Newron. The institution of Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for acadia. Dr. Grossberg has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for biogen. Dr. Grossberg has received publishing royalties from a publication relating to health care. Dr. Grossberg has received publishing royalties from a publication relating to health care.
Daniel Lee (Otsuka) No disclosure on file
Mary Slomkowski (Otsuka) No disclosure on file
Nanco Hefting (H. Lunbdeck A/S) No disclosure on file
Dalei Chen No disclosure on file
Mary Hobart Mary Hobart has received personal compensation for serving as an employee of Otsuka Pharmaceutical Development & Commercialization, Inc..
Jeffrey L. Cummings, MD, FAAN Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ACADIA. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alkahest. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche/Genentech. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Green Valley. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Grifols. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novo Nordisk. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Otsuaka. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving as a Consultant for United Neuroscience. Dr. Cummings has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Cummings has received research support from NIH. Dr. Cummings has received intellectual property interests from a discovery or technology relating to health care.