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 | |
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MD First Research, LLC
Chandler, AZ 85286
Recruiting
Ashely Mitchell |
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| California | |
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CiTrials Inc
Bellflower, CA 90706
Recruiting
Maribel Balderas |
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ATP Clinical Research, Inc.
Costa Mesa, CA 92626
Recruiting
Bobby Shih |
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HB Clinical Trials, Inc.
Fountain Valley, CA 92708
Recruiting
Nancy Alexander |
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Neuro Pain Medical Center
Fresno, CA 93710
Recruiting
Isha Monga |
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Irvine Clinical Research
Irvine, CA 92614
Recruiting
Kimberly Guevarra |
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Shreenath Clinical Service
Lakewood, CA 90805
Recruiting
Kiran Shah |
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Havana Research Institute LLC
Pasadena, CA 91105
Recruiting
Jasmine Gomez |
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| Florida | |
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Advanced Clinical Research
Coral Gables, FL 33134
Recruiting
Ishi Calderin |
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Galiz Research
HIALEAH, FL 33016
Recruiting
Ernesto Leyva |
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Research in Miami Inc
Hialeah, FL 33013
Recruiting
Orlando Sanchez |
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New Life Medical Research Center, Inc.
Hialeah, FL 33012
Recruiting
Yunior Silva-Barrero |
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Direct Helpers Research Center
HIALEAH, FL 33012
Recruiting
Vanessa Valdes |
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Premier Clinical Research Institute, Inc.
Miami, FL 33122
Recruiting
Yvette Cortes |
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Allied Biomedical Research Institute
Miami, FL 33155
Recruiting
Elvira Grana |
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Project4Research, Inc.
Miami, FL 33125
Recruiting
Lisette Portes |
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Health Care Family Rehab & Research
Miami, FL 33015
Recruiting
Vivian Torres |
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LC Professional Medical Research Institute
Miami, FL 33144
Recruiting
Geidy Figueras |
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Central Miami Medical Institute
Miami, FL 33125
Recruiting
Melissa Ocana |
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International Research Associates, LLC
Miami, FL 33183
Recruiting
Gustavo Canelon |
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P & S Research, LLC
Miami, FL 33175
Recruiting
Miguel Pena |
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The Neurology Research Group
Miami, FL 33176
Recruiting
Nerline Monestime |
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South Florida Research Phase I-IV, Inc.
Miami Springs, FL 33166
Recruiting
Lisbelle Revoredo |
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Health Synergy Clinical Research
Okeechobee, FL 34972
Recruiting
Marina Winberg |
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Combined Research Orlando
Orlando, FL 32807
Recruiting
Estevez Yenilady |
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IMIC Inc
Palmetto Bay, FL 33157
Recruiting
Adriana Tijerino |
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Humanity Clinical Research
Pembroke Pines, FL 33024
Recruiting
Elena Guerrero |
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Quantum Laboratories
Pompano Beach, FL 33064
Recruiting
Karen Herr |
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VICIS Clinical Research
Tampa, FL 33615
Recruiting
Yurima Jimenez |
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Bayside Medical Group
Trinity, FL 34655
Recruiting
Yanira Mandina |
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| Georgia | |
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Advanced Discovery Research
Atlanta, GA 30318
Recruiting
Syed Ahmed |
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Georgia Neurology and Sleep Medicine Associates
Suwanee, GA 30024
Recruiting
Trista Grant |
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| Massachusetts | |
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Alzheimer Disease Center
Winchester, MA 01890
Recruiting
Kanjolia Mahak |
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| Michigan | |
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Oakland Medical Research
Troy, MI 48085
Recruiting
Julie Lafave |
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| Mississippi | |
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Precise Research Centers
Flowood, MS 39232
Recruiting
Stesh Oliver |
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| Missouri | |
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Arch Clinical Trials, LLC
St. Louis, MO 63125
Recruiting
Angela Trammel |
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| New Jersey | |
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Bio Behavioral Health
Toms River, NJ 08755
Recruiting
Dawn Arnone |
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Ocean Medical Research
Toms River, NJ 08755
Recruiting
Dawn Arnone |
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| New York | |
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Integrative Clinical Trials LLC
Brooklyn, NY 11229
Recruiting
Bella Yevseva |
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Evolution Research Group
New York, NY 10312
Recruiting
Nicole Corona |
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Five Towns Neurology PC/Villiage
Woodmere, NY 11598
Recruiting
Aaron Spiegel |
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| North Carolina | |
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Mind Path Care Centers, North Carolina, PLLC
Raleigh , NC 27606
Recruiting
Jennifer Wood |
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| Texas | |
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Relaro Medical Trials
Dallas, TX 75243
Recruiting
Selam Beyene |
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Northpointe Psychiatry
Lewisville, TX 75057
Recruiting
Sahar Ashraf |
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Epic Medical Research
Red Oak, TX 75154
Recruiting
Haresh Boghara |
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Who Sponsors This Study?
Lead: Otsuka Pharmaceutical Development and Commercialization, Inc.
Collaborator Sponsor
- H. Lundbeck A/S
Source: ClinicalTrials.gov ID: NCT03548584