Alzheimer's Disease Education and Referral Center

Brexpiprazole for Agitation in Alzheimer's Dementia

Brexpiprazole for Agitation in Alzheimer's Dementia

Overall Status: 
Brief Description: 

This study will assess the efficacy of the experimental drug brexpiprazole, compared to a placebo, in people who have agitation due to Alzheimer's dementia.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
90 Years
Inclusion Criteria: 
    • Living either in a long-term care setting (dementia unit, nursing home, or assisted living facility) or in a noninstitutionalized setting with at least one other person
    • Diagnosis of probable Alzheimer's disease
    • Mini Mental State Examination score of 5 to 22, inclusive, at screening and baseline visits
    • Onset of agitation symptoms at least 2 weeks prior to screening; score of ≥ 4 on the agitation/aggression item of the Neuropsychiatric Inventory-Nursing Home Rating Scale; requires pharmacotherapy for treatment of agitation in investigator's judgment, after an evaluation for reversible factors, such as pain or infection, and nonpharmacological intervention
    • Previous MRI or CT scan, performed after the onset of dementia symptoms, consistent with a diagnosis of Alzheimer's disease
Exclusion Criteria: 
    • Dementia or other memory impairment due to cause other than Alzheimer's disease
    • History of stroke, transient ischemic attack, pulmonary or cerebral embolism, or traumatic brain injury
    • Deep vein thrombosis within 5 years prior to the screening visit
    • Diagnosis of psychiatric disorders (Axis I and Axis II per DSM-IV-TR criteria)
    • Uncontrolled hypertension
    • Uncontrolled, insulin-dependent diabetes mellitus without current microalbuminuria
    • Epilepsy or a history of seizures
    • Bedridden
    • Clinically significant infection, with treatment with intravenous antibiotics or hospitalization, within 2 weeks of screening
    • Inability to swallow tablets or tolerate oral medication
Detailed Description: 

Agitation is a common behavioral symptom in people with Alzheimer's disease and places a significant burden on people with the disease, their caregivers, and the healthcare system. This Phase III trial is designed to assess the safety and efficacy of the experimental drug brexpiprazole as a treatment for agitation in people with Alzheimer's dementia. Three different doses will be compared to a placebo during the 12-week treatment period. Brexipiprazole, which acts on dopamine receptors, is a tablet taken once a day.

Central Contact Information: 

For more information about this clinical trial, contact Rozina Jadoon at 1-919-418-6218 or

Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 43.0116784, -88.2314813

Lead Sponsor: 
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator Sponsor: 
H. Lundbeck A/S
Facility Investigators: 
Eva Kohegyi, MD
Study Director
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact: 
Rozina Jadoon
Locations ID 
NCT01862640 (follow link to view full record on in new window)
Official Title: 
A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 3 Fixed Doses of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia
Study Start Date: 
July 2013
Study End Date: 
June 2017
Disease Stage: