Skip to main content
Find more clinical trials

Brexpiprazole for Agitation in Alzheimer's

Start: May 16, 2018
End: April 2022
Enrollment: 330

What Is This Study About?

This Phase 3 study will compare the efficacy of two different doses of brexpiprazole (Rexulti) with placebo in older adults who are experiencing agitation (emotionally distressed, restless, or aggressive) associated with Alzheimer's disease. Participants will be randomly assigned to take a low- or high-dose tablet of brexpiprazole or a placebo for 12 weeks. Brexpiprazole has been approved by the U.S. Food and Drug Administration for the treatment of schizophrenia and depression. Researchers will measure changes in the frequency and severity of agitated behaviors. Participants may be eligible to enter a follow-up trial.

Do I Qualify To Participate in This Study?

Minimum Age: 55 Years

Maximum Age: 90 Years

Must have:

  • Diagnosis of Alzheimer's disease
  • Diagnosis of agitation, with the onset of symptoms at least two weeks prior to the screening visit
  • Mini-Mental State Examination score of 5 to 22
  • Findings on MRI or CT 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

Must NOT have:

  • 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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Who Is the General Study Contact?

For more information and to enroll, visit the Brex ADD study website or call 844-687-8522.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Arizona
MD First Research, LLC
Chandler, AZ 85286
Recruiting
Ashely Mitchell
California
CiTrials Inc
Bellflower, CA 90706
Recruiting
Maribel Balderas
ATP Clinical Research, Inc.
Costa Mesa, CA 92626
Recruiting
Bobby Shih
HB Clinical Trials, Inc.
Fountain Valley, CA 92708
Recruiting
Nancy Alexander
Neuro Pain Medical Center
Fresno, CA 93710
Recruiting
Isha Monga
Irvine Clinical Research
Irvine, CA 92614
Recruiting
Kimberly Guevarra
Shreenath Clinical Service
Lakewood, CA 90805
Recruiting
Kiran Shah
Havana Research Institute LLC
Pasadena, CA 91105
Recruiting
Jasmine Gomez
Florida
Advanced Clinical Research
Coral Gables, FL 33134
Recruiting
Ishi Calderin
Galiz Research
HIALEAH, FL 33016
Recruiting
Ernesto Leyva
Research in Miami Inc
Hialeah, FL 33013
Recruiting
Orlando Sanchez
New Life Medical Research Center, Inc.
Hialeah, FL 33012
Recruiting
Yunior Silva-Barrero
Direct Helpers Research Center
HIALEAH, FL 33012
Recruiting
Vanessa Valdes
Premier Clinical Research Institute, Inc.
Miami, FL 33122
Recruiting
Yvette Cortes
Allied Biomedical Research Institute
Miami, FL 33155
Recruiting
Elvira Grana
Project4Research, Inc.
Miami, FL 33125
Recruiting
Lisette Portes
Health Care Family Rehab & Research
Miami, FL 33015
Recruiting
Vivian Torres
LC Professional Medical Research Institute
Miami, FL 33144
Recruiting
Geidy Figueras
Central Miami Medical Institute
Miami, FL 33125
Recruiting
Melissa Ocana
International Research Associates, LLC
Miami, FL 33183
Recruiting
Gustavo Canelon
P & S Research, LLC
Miami, FL 33175
Recruiting
Miguel Pena
The Neurology Research Group
Miami, FL 33176
Recruiting
Nerline Monestime
South Florida Research Phase I-IV, Inc.
Miami Springs, FL 33166
Recruiting
Lisbelle Revoredo
Health Synergy Clinical Research
Okeechobee, FL 34972
Recruiting
Marina Winberg
Combined Research Orlando
Orlando, FL 32807
Recruiting
Estevez Yenilady
IMIC Inc
Palmetto Bay, FL 33157
Recruiting
Adriana Tijerino
Humanity Clinical Research
Pembroke Pines, FL 33024
Recruiting
Elena Guerrero
Quantum Laboratories
Pompano Beach, FL 33064
Recruiting
Karen Herr
VICIS Clinical Research
Tampa, FL 33615
Recruiting
Yurima Jimenez
Bayside Medical Group
Trinity, FL 34655
Recruiting
Yanira Mandina
Georgia
Advanced Discovery Research
Atlanta, GA 30318
Recruiting
Syed Ahmed
Georgia Neurology and Sleep Medicine Associates
Suwanee, GA 30024
Recruiting
Trista Grant
Massachusetts
Alzheimer Disease Center
Winchester, MA 01890
Recruiting
Kanjolia Mahak
Michigan
Oakland Medical Research
Troy, MI 48085
Recruiting
Julie Lafave
Mississippi
Precise Research Centers
Flowood, MS 39232
Recruiting
Stesh Oliver
Missouri
Arch Clinical Trials, LLC
St. Louis, MO 63125
Recruiting
Angela Trammel
New Jersey
Bio Behavioral Health
Toms River, NJ 08755
Recruiting
Dawn Arnone
Ocean Medical Research
Toms River, NJ 08755
Recruiting
Dawn Arnone
New York
Integrative Clinical Trials LLC
Brooklyn, NY 11229
Recruiting
Bella Yevseva
Evolution Research Group
New York, NY 10312
Recruiting
Nicole Corona
Five Towns Neurology PC/Villiage
Woodmere, NY 11598
Recruiting
Aaron Spiegel
North Carolina
Mind Path Care Centers, North Carolina, PLLC
Raleigh , NC 27606
Recruiting
Jennifer Wood
Texas
Relaro Medical Trials
Dallas, TX 75243
Recruiting
Selam Beyene
Northpointe Psychiatry
Lewisville, TX 75057
Recruiting
Sahar Ashraf
Epic Medical Research
Red Oak, TX 75154
Recruiting
Haresh Boghara

Who Sponsors This Study?

Lead: Otsuka Pharmaceutical Development and Commercialization, Inc.

Collaborator Sponsor

  • H. Lundbeck A/S

Source: ClinicalTrials.gov ID: NCT03548584