Evidence map›Paper›PMID 40847656›Full record

Trial reportCurrent medical research and opinion2025

Brexpiprazole for agitation in clinically relevant patient subgroups: a

Jared Stroud, Jeffrey L Cummings, Sanjeda R Chumki, Pedro Such, David Wang, Anton M Palma, Zhen Zhang, Malaak Brubaker, George T Grossberg

2 registry-linked trialsAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Current medical research and opinion, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01862640 phase3completednot on this map

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2013 to 2017Enrolled433ConditionsAgitation Associated With, Alzheimer's Disease, Alzheimer's Type, Mental DisorderArmsBrexpiprazole, OPC-34712, Placebo Oral Tablet
NCT03548584 phase3completednot on this map

A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2018 to 2022Enrolled345ConditionsAgitation Associated With Alzheimer's Dementia, Alzheimer DementiaArmsBrexpiprazole, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Review
  3. Observational
  4. Beyond the Outburst: Charting a New Frontier for Understanding and Treating Irritability in Autistic Adults.Autism research : official journal of the International Society for Autism Research · 2026
    Review
  5. Article
  6. Brexpiprazole for the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease: Clinical Perspectives.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2026
    Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Jared StroudOhio State University Wexner Medical Center, Columbus, OH, USA.
Jeffrey L CummingsDepartment of Brain Health, Chambers-Grundy Center for Transformative Neuroscience, Kirk Kerkorian School of Medicine, University of Nevada, Las Vegas, NV, USA.ORCID 0000-0001-8944-4158
Sanjeda R ChumkiMedical Affairs, Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, NJ, USA.
Pedro SuchMedical Affairs, H. Lundbeck A/S, Valby, Denmark.
David WangMedical Affairs, Lundbeck LLC, Deerfield, IL, USA.
Anton M PalmaMedical and Real-World Data Analytics, Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, NJ, USA.
Zhen ZhangMedical and Real-World Data Analytics, Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, NJ, USA.
Malaak BrubakerMedical Affairs, Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, NJ, USA.
George T GrossbergDepartment of Psychiatry and Behavioral Neuroscience, Saint Louis University School of Medicine, St. Louis, MO, USA.ORCID 0000-0002-1493-3931

Funding

Renewal of Centers of Biomedical Research Excellence (COBRE) (Phase 2) CNTN - ResubmissionP20GM109025 · NIGMS · CLEVELAND CLINIC FOUNDATION · PI JESSICA KIRKLAND CALDWELL · 2015 to 2026
$22.8M
Risk and Resilience, Clinical presentation, and Biomarker Profiles of Chronic Traumatic Encephalopathy and Related Dementias: The DIAGNOSE CTE Research Project IIR01NS139383 · NINDS · BOSTON UNIVERSITY MEDICAL CAMPUS · PI Michael Alosco, Nicholas Ashton · 2024 to 2026
$9.3M
Alzheimer's Clinical Trial InnOvatioN (ACTION) InitiativeR35AG071476 · NIA · UNIVERSITY OF NEVADA LAS VEGAS · PI CUMMINGS, JEFFREY L. · 2021 to 2025
$2.9M
Alzheimer's Disease and Related Dementias Innovation Incubator (InnovaTor)R25AG083721 · NIA · UNIVERSITY OF NEVADA LAS VEGAS · PI JEFFREY L. CUMMINGS, Xue K Zhong · 2023 to 2026
$1.0M
NIA NIH HHS R25 AG083721NIA NIH HHS R35 AG071476NIGMS NIH HHS P20 GM109025NINDS NIH HHS R01 NS139383
6 · The paper itself

Abstract

objectiveTo explore the efficacy and safety of brexpiprazole for the treatment of agitation symptoms in clinically relevant subgroups of patients with dementia due to Alzheimer's disease.

methodsData were pooled for brexpiprazole (2 or 3 mg/day) and placebo from two international, randomized, double-blind trials in adults with a clinical diagnosis of Alzheimer's dementia with mild-to-severe cognitive dysfunction and with agitation (ClinicalTrials.gov identifiers: NCT01862640, NCT03548584). Change in agitation frequency over 12 weeks was measured using the Cohen-Mansfield Agitation Inventory (CMAI). Safety measures included treatment-emergent adverse events (TEAEs). In this

resultsIn the randomized sample (

conclusionIn these exploratory analyses, brexpiprazole reduced symptoms of agitation across a wide range of patients with agitation associated with dementia due to Alzheimer's disease.

Indexed as

Alzheimer DiseaseAntipsychotic AgentsPsychomotor AgitationQuinolonesThiophenesAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAntipsychotic AgentsbrexpiprazoleQuinolonesThiophenesAlzheimer’s diseaseantipsychotic agentsbrexpiprazoleclinical trialdementiapsychomotor agitation

Identifiers

PMID40847656
PMCPMC13559474

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.