Brexpiprazole, OPC-34712

DRUG2 trials

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

Conditions

Agitation Associated WithAlzheimer's DiseaseAlzheimer's TypeMental DisorderNervous System Diseases

Phase 3

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 in the Treatment of Alzheimer's Agitation

CompletedNCT01862640

Otsuka Pharmaceutical Development & Commercialization, Inc.Agitation Associated With, Alzheimer's Disease, Alzheimer's Type +2

Start: 2013-07-11End: 2017-03-15Updated: 2020-12-31

Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

CompletedNCT01922258

Otsuka Pharmaceutical Development & Commercialization, Inc.Agitation Associated With, Alzheimer's Disease, Alzheimer's Type +2

Start: 2013-09-30End: 2017-03-31Updated: 2020-11-20

Related Papers

Short-Term and Long-Term Safety Analyses of Brexpiprazole for Agitation Associated with Dementia due to Alzheimer's Disease: Timing and Duration of Adverse Events.

2026-04-10

Efficacy of Brexpiprazole in Participants with Agitation Associated with Dementia Due to Alzheimer's Disease: Pooled Analysis of Randomized Controlled Trials.

2026-01-27

Efficacy of Brexpiprazole on Neuropsychiatric Symptoms and Impact on Caregivers: Pooled Neuropsychiatric Inventory (NPI) Analysis in Patients With Agitation Associated With Dementia due to Alzheimer's Disease.

2025-12-24

Brexpiprazole for agitation in clinically relevant patient subgroups: a <i>post hoc</i> analysis of efficacy and safety in patients with agitation associated with dementia due to Alzheimer's disease.

2025-08-01

Safety and Tolerability of Brexpiprazole in Participants with Agitation Associated with Dementia due to Alzheimer's Disease: Pooled Analysis of Three Randomized Trials and an Extension Trial.

2025-07-191 citations

Long-term safety and tolerability of brexpiprazole for Japanese patients with agitation in Alzheimer's disease dementia: A multicenter, open-label study

Journal of Alzheimer s Disease Reports2025-04-162 citations

Efficacy of brexpiprazole on agitation in patients with dementia due to Alzheimer’s disease exhibiting behaviors most bothersome to caregivers: <i>post hoc</i> pooled analysis of two randomized controlled trials

Alzheimer s & Dementia2024-12-011 citations

Efficacy of brexpiprazole on frequently occurring agitation behaviors in patients with dementia due to Alzheimer’s disease: <i>post hoc</i> pooled analysis of two randomized controlled trials

Alzheimer s & Dementia2024-12-01

Defining a clinically meaningful within-patient change threshold for the Cohen-Mansfield Agitation Inventory in Alzheimer’s dementia

Frontiers in Neurology2024-07-2310 citations

P170: Safety and Tolerability of Brexpiprazole for the Treatment of Agitation in Alzheimer’s Dementia: Pooled Results From Three Phase III Trials

International Psychogeriatrics2023-12-01

P96: Efficacy of Brexpiprazole for the Treatment of Agitation in Alzheimer’s Dementia: Post Hoc Line Item Analysis of the Cohen-Mansfield Agitation Inventory

International Psychogeriatrics2023-12-01

Efficacy and Safety of Brexpiprazole for the Treatment of Agitation in Alzheimer's Dementia: Two 12-Week, Randomized, Double-Blind, Placebo-Controlled Trials.

2019-10-0198 citations