Alzheimer's Disease Education and Referral Center

Brexpiprazole for Agitation in Alzheimer's Dementia

Brexpiprazole for Agitation in Alzheimer's Dementia

Overall Status: 
Recruiting
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 and are living in a hospital dementia unit, nursing home, assisted living facility, or other residential care facility.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
90 Years
Both
No
Inclusion Criteria: 
    • Living in a hospital dementia unit, nursing home, assisted living facility, or other residential care facility for at least 1 month before screening and planning to remain at the same facility for the duration of the trial
    • 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 Version; 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, 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
    • Insulin-dependent diabetes mellitus
    • 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 long-term care residents 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 rozina.jadoon@incresearch.com.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.6496252, -117.9190418

Site
Costa Mesa
California
92627
Recruiting
Name:
Phone:

Geolocation is 33.9372725, -118.1298234

Site
Downey
California
90241
Recruiting
Name:
Phone:

Geolocation is 34.0555693, -117.1825381

Site
Redlands
California
92373
Recruiting
Name:
Phone:

Geolocation is 33.9011405, -117.7959713

Site
Yorba Linda
California
92886
Recruiting
Name:
Phone:

Geolocation is 41.1339818, -73.4062342

Site
Norwalk
Connecticut
06851
Recruiting
Name:
Phone:

Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Recruiting
Name:
Phone:

Geolocation is 25.8909628, -80.1819268

Site
Miami
Florida
33161
Recruiting
Name:
Phone:

Geolocation is 25.7616792, -80.3491599

Site
Miami
Florida
33174
Recruiting
Name:
Phone:

Geolocation is 25.8223198, -80.289495

Site
Miami Springs
Florida
33166
Recruiting
Name:
Phone:

Geolocation is 33.8092255, -84.2805478

Site
Decatur
Georgia
30033
Recruiting
Name:
Phone:

Geolocation is 40.9259319, -74.6348828

Site
Mt. Arlington
New Jersey
07856
Recruiting
Name:
Phone:

Geolocation is 40.0207099, -74.2061931

Site
Toms River
New Jersey
08755
Recruiting
Name:
Phone:

Geolocation is 43.0116784, -88.2314813

Site
Waukesha
Wisconsin
53188
Recruiting
Name:
Phone:
Lead Sponsor: 
Agency
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator Sponsor: 
Agency
H. Lundbeck A/S
Facility Investigators: 
NameRoleAffiliation
Stacy Wu, MD
Study Director
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact: 
NamePhoneEmail
Rozina Jadoon
919-418-6218
Locations
 
 
ClinicalTrials.gov ID 
NCT01862640 (follow link to view full record on ct.gov 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: 
Late
Enrollment: 
560