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Brexpiprazole for Agitation in Alzheimer's


This Phase III study compares the efficacy of two different doses of brexpiprazole (Rexulti) with placebo in older adults who are experiencing agitation associated with Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 90 Years All No
May 16, 2018
December 2020

  • Diagnosis of probable Alzheimer's disease
  • Diagnosis of agitation, with onset of symptoms at least 2 weeks prior to the screening visit
  • Mini-Mental State Examination score of 5 to 22
  • Findings on magnetic resonance imaging or computed tomography brain scan consistent with Alzheimer's
  • Residence at current location for at least 28 days with no immediate plans to move
  • Caregiver who can observe and describe the participant's symptoms and behavior

  • Dementia or other memory impairment not due to Alzheimer's
  • History of stroke, transient ischemic attack, or pulmonary or cerebral embolism
  • Insufficient response to two or more previous antipsychotic medications
  • Diagnosis of a DSM-V Axis I psychological disorder
  • Clinically significant neurological, liver, kidney, metabolic, blood, immunological, heart, lung, gastrointestinal, or psychiatric disorder
  • Uncontrolled low or high blood pressure
  • Uncontrolled diabetes

Participants will be randomly assigned to take a low- or high-dose tablet of brexpiprazole or a placebo for 12 weeks. Brexpiprazole is an atypical antipsychotic that has been approved by the U.S. Food and Drug Administration for treatment of schizophrenia and depression. Researchers will measure changes in frequency and severity of agitated behaviors. Participants may be eligible to enter an extension trial.

For more information about this clinical trial or the study sites, please call Rozina Jadoon at 1-919-418-6218 or email

Name City State Zip Status Primary Contact
For additional information regarding sites, contact 844-687-8522
Los Angeles California 90036 Recruiting

Otsuka Pharmaceutical Development and Commercialization, Inc.

  • H. Lundbeck A/S


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