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A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

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ClinicalTrials.gov Identifier: NCT03548584
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : July 12, 2019
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
This study compares the efficacy of 2 doses of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type.

Condition or disease Intervention/treatment Phase
Agitaton Associated With Alzheimer's Dementia Alzheimer Dementia Drug: Brexpiprazole Other: Placebo Phase 3

Detailed Description:
This is a phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the efficacy, safety, and tolerability of brexpiprazole compared with placebo. The trial consists of a 12-week double-blind treatment period with a 30 day follow-up. The trial population will include male and female subjects between 55 and 90 years of age (inclusive) with a diagnosis of probable Alzheimer's disease, who are residing either in an institutionalized setting or in a non-institutionalized setting where the subject is not living alone. This trial will analyze data gathered from 225 subjects at multiple countries. Subjects may also be eligible to enter an active extension trial, following completion of this trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 the Alzheimer's Type
Actual Study Start Date : May 16, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Low Dose Brexpiprazole Arm
Tablet
Drug: Brexpiprazole
Tablet
Other Name: OPC-34712

Experimental: High Dose Brexpiprazole Arm
Tablet
Drug: Brexpiprazole
Tablet
Other Name: OPC-34712

Placebo Comparator: Placebo
Tablet
Other: Placebo
Tablet




Primary Outcome Measures :
  1. Cohen-Mansfield Agitation Inventory (CMAI) total score [ Time Frame: From baseline to week 12 visit ]
    Change from baseline to Week 12; assesses frequency of agitated behaviors in elderly persons. The scale consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. Each of the agitated behaviors are scored 1 (never) to 7 (several times an hours), with the total scale score ranging from 29 to 203. The higher the value, the more frequent an agitated behavior has occurred.


Secondary Outcome Measures :
  1. Clinical Global Impression Severity of Illness (CGI-S) score [ Time Frame: From baseline to week 12 visit ]
    Change from baseline to week 12, as related to agitation. CGI-S will be used to rate the severity of agitation. Score ranges from 0 (not assessed) to 7 (among the most extremely ill subjects). The higher the value, the more severe the agitation.



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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of probable Alzheimer's disease.
  • Subjects with a diagnosis of agitation
  • Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.
  • Subjects with a previous MRI or CT scan of the brain, that was performed after the onset of symptoms of dementia, with findings consistent with a diagnosis of Alzheimer's disease.
  • Subjects who are residing at their current location for at least 28 days before screening and are expected to remain at the same location for the duration of the trial.
  • Institutionalized subjects with an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject's symptoms and has direct observation of the subject's behavior. Non-institutionalized subjects may not be living alone and must have an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject's symptoms and has direct observation of the subject's behavior.
  • Subjects with onset of symptoms of agitation at least 2 weeks prior to screening visit.
  • Subjects will and able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period.

Exclusion Criteria:

  • Subjects with dementia or other memory impairment not due to Alzheimer's disease.
  • Subjects with a history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.
  • Subjects who had an insufficient response, based on the investigator's judgment, to 2 or more previous antipsychotic medications.
  • Subjects who have been diagnosed with an Axis I disorder.
  • Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
  • Subjects with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension.
  • Subjects with diabetes mellitus (insulin-dependent and non-insulin-dependent) may be eligible for the trial if their condition is stable and well-controlled.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548584


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Locations
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United States, Arizona
MD First Research, LLC Recruiting
Chandler, Arizona, United States, 85226
Contact: Hemant Pandey, M.D.    480-353-6462    hpandey@brainandspineaz.com   
Territory Neurology & Research Institute Withdrawn
Tucson, Arizona, United States, 85704
United States, California
ATP Clinical Research Inc. Recruiting
Costa Mesa, California, United States, 92626
Contact: Gustavo Alva, M.D.    714-277-4472    galva@atpcr.com   
Global Clinical Trials Recruiting
Costa Mesa, California, United States, 92627
Contact: Jason Kellogg, M.D.    949-660-8211    drkellogg@globalclinicaltrials.org   
Neurology Center of North Orange County Withdrawn
Fullerton, California, United States, 92835
Irvine Clinical Research Recruiting
Irvine, California, United States, 92614
Contact: Elly Lee    949-753-1663    elee@irvineclinical.com   
Shreenath Clinical Services Recruiting
Lakewood, California, United States, 90805
Contact: Gnyandev Patel, M.D.    714-717-6039    gpatelresearch@aol.com   
Axis Clinical Trials Recruiting
Los Angeles, California, United States, 90036
Contact: Lydia Hazan, M.D.    310-289-8242    drhazan@axistoday.com   
Califnoria Neurological Services Recruiting
Panorama City, California, United States, 91402
Contact: Nader Armanious    818-894-3111    Naderneuro@gmail.com   
SC3 Research Recruiting
Pasadena, California, United States, 91105
Contact: Richard Shubin, M.D.    626-250-2070    shubinpi@neurosearch-usa.com   
United States, Florida
Nova Clinical Research Recruiting
Bradenton, Florida, United States, 34209
Contact: Francisco Esparza, M.D.    941-792-6564    Francisco.Esparza@novaclinicalresearch.com   
Advanced Clinical Research Recruiting
Coral Gables, Florida, United States, 33134
Contact: Gil Fernandez-Yera, M.D.    305-702-1594    gilfyeramd@acrntrials.com   
Arocha Research Center Recruiting
Coral Gables, Florida, United States, 33134
Contact: Emelina Arocha, M.D.    786-587-9425    emelinaarochamd@gmail.com   
ICR Sites, LLC Recruiting
Doral, Florida, United States, 33166
Contact: Adolfo Cueli    305-552-7660    acuelimd@icrsites.com   
Direct Helpers Research Center Recruiting
Hialeah, Florida, United States, 33012
Contact: Manuel Fernandez    305-828-3555    Fernandez@dhrtrials.com   
Research in Miami Inc. Recruiting
Hialeah, Florida, United States, 33013
Contact: Dolores Sanchez-Cazau, M.D.    305-889-6670    dcazau@researchinmiami.com   
Galiz Research Recruiting
Hialeah, Florida, United States, 33016
Contact: Jose Gamez, M.D.    305-805-0921    jegamez@galizresearch.com   
MaxBlue Institute Recruiting
Hialeah, Florida, United States, 33018
Contact: Ziad Hawathmeh, M.D.    305-819-2909    drziad@maxblueresearch.com   
SIH Research Recruiting
Kissimmee, Florida, United States, 34741
Contact: Syed Mumtaz, M.D.    407-932-1977    research.sih@gmail.com   
Ocean Blue Medical Research Recruiting
Miami Springs, Florida, United States, 33166
Contact: Richard Dreize    305-885-8983    Richard.dreize@obmedresearch.com   
Premier Clinical Research Recruiting
Miami, Florida, United States, 33122
Contact: Emilio Mantero-Atienza, M.D.    305-392-0279    emantero@pcrinstitute.com   
Central Miami Medical Institute Recruiting
Miami, Florida, United States, 33125
Contact: Leonardo Alonso    305-547-2011    leonardo.alonsomd@gmail.com   
Allied Biomedical Research Institute Recruiting
Miami, Florida, United States, 33155
Contact: Michael Pfeffer, M.D.    305-643-8400    mpfeffer@abriusa.net   
Janus Clinical Research Recruiting
Miami, Florida, United States, 33186
Contact: Oscar Hernandez    786-360-4364    hernandezmd@januscr.net   
IMIC Inc. Recruiting
Palmetto Bay, Florida, United States, 34209
Contact: Evelyn Lopez-Brignoni, M.D.    786-310-7477    evelyn@aktamedika.com   
Health Care Family Research 2 Recruiting
Pembroke Pines, Florida, United States, 33024
Contact: Elizabeth Mones    954-342-9557    EMonesResearch@gmail.com   
University of West Florida (UWF) Clinical Trials Recruiting
Pensacola, Florida, United States, 32514
Contact: Rodney Guttmann, M.D.    850-474-3449    Rguttmann@uwf.edu   
Clinovation Research, LLC Withdrawn
Weston, Florida, United States, 33327
United States, Georgia
Georgia Neurology and Sleep Medicine Associates Recruiting
Suwanee, Georgia, United States, 30024
Contact: David Lesch, M.D.    770-814-9455    dlesch@ganeurosleep.com   
United States, Massachusetts
Alzheimer Disease Center Recruiting
Winchester, Massachusetts, United States, 01890
Contact: Anil Nair, M.D.    617-639-5006    nair.anil@gmail.com   
United States, Michigan
Michigan Clinical Research Institute PC Withdrawn
Ann Arbor, Michigan, United States, 48105
United States, Mississippi
Precise Research Centers Recruiting
Flowood, Mississippi, United States, 39232
Contact: Joseph Kwentus, M.D.    601-420-5811    jkwentus@precise-research.com   
United States, Missouri
Arch Clinical Trials Recruiting
Saint Louis, Missouri, United States, 63118
Contact: Junaid Syed, M.D.    314-230-4326    drsyed@archclinicaltrials.com   
United States, New Jersey
Bio Behavioral Health Recruiting
Toms River, New Jersey, United States, 08755
Contact: Ashok Patel, M.D.    732-244-2299    ap@bbhnj.com   
United States, New York
Neurological Associates of Albany ,PC Recruiting
Albany, New York, United States, 12208
Contact: Richard Holub    518-426-0575    rholub@naaresearch.com   
Integrative Clinical Trials LLC Recruiting
Brooklyn, New York, United States, 11229
Contact: Inna Yuryev-Golger, M.D.    718-444-7774    igolger@iclinicaltrials.net   
Five Towns Neurology PC/Villiage Recruiting
Woodmere, New York, United States, 11598
Contact: David Steiner    516-239-1800    drsteiner@ftniresearch.com   
United States, North Carolina
Richard H. Weisler, MD PA Associates Recruiting
Raleigh, North Carolina, United States, 27609
Contact: Richard Weisler, M.D.    919-872-5900    rweisler@weislermd.com   
United States, Pennsylvania
Lehigh Center for Clinical Research Withdrawn
Allentown, Pennsylvania, United States, 18104
United States, Texas
Gadolin Research, LLC Recruiting
Beaumont, Texas, United States, 77702
Contact: Jason Mensah, M.D.    409-331-6040    Jmensah@gadolinresearch.com   
Centex Studies Inc. Recruiting
Houston, Texas, United States, 77058
Contact: Amro El Feki, M.D.    281-282-0808    aelfeki@centexstudies.com   
Bio Pharma Informatic Inc. Recruiting
Houston, Texas, United States, 77084
Contact: Ashok Jain, M.D.    281-944-3610    ashok@clinicalrc.net   
Northpointe Psychiatry Recruiting
Lewisville, Texas, United States, 75057
Contact: Asad Islam    214-799-8277    northpointe.research@gmail.com   
Bulgaria
Mental Health Center Prof. Dr Ivan Temkov - Burgas EOOD Recruiting
Burgas, Bulgaria, 8000
Contact: Veselin Palazov, M.D.    359-56816298    vpalazov@abv.bg   
State Psychiatry Hospital - Kardzhali Recruiting
Kardzhali, Bulgaria, 6600
Contact: Rozaliya Rangelova, M.D.    359 36162715    rrangelova80@abv.bg   
Mental Health Centre-Ruse EOOD, Daily Unit Recruiting
Ruse, Bulgaria, 7003
Contact: Temenuzhka Dechkova-Novakova, M.D.    359-878435010    mateva_rs@mail.bg   
Medical Center Sveti Naum EOOD Recruiting
Sofia, Bulgaria, 1113
Contact: Assen Karadaliev, M.D.    35929702139    karadaliev@hotmail.com   
Medical Center Intermedica OOD Recruiting
Sofia, Bulgaria, 1680
Contact: Toni Donchev, M.D.    359-895-556767    tonyd@abv.bg   
Diagnostic and Consultative Centre Mladost - M Varna OOD Recruiting
Varna, Bulgaria, 9020
Contact: Hristo Kozhuharov, M.D.    359 888 816 035    christokojuharov@abv.bg   
Diagnostic and Consultative Centre Mladost - M Varna OOD Recruiting
Varna, Bulgaria, 9020
Contact: Petar Petrov, M.D.    359 888 940142    pmdown@abv.bg   
Mental Health Center - Vratsa EOOD Recruiting
Vratsa, Bulgaria, 3000
Contact: Nadya Ivanova, M.D.    359-887-422-440    nadia_odpzs@abv.bg   
Serbia
Clinical Hospital Center "Dr. Dragisa Misovic - Dedinje" Recruiting
Belgrade, Serbia, 11000
Contact: Vladimir Diligenski, M.D.    381637708765    dilig@eunet.rs   
Special Hospital for Psychiatric Diseases "Kovin" Recruiting
Kovin, Serbia, 26220
Contact: Jovanka Petrovic, M.D.    38163529054    petrovicjoka@yahoo.com   
Clinical Center Kragujevac Recruiting
Kragujevac, Serbia, 34000
Contact: Vladimir Janjic, M.D.    381641133706    vladadok@yahoo.com   
Clinical Center of Vojvodina Recruiting
Novi Sad, Serbia, 21000
Contact: Marija Semnic    381 638370578    memoryns@gmail.com   
Spain
Centro de Salud San Juan Recruiting
Salamanca, Spain, 37005
Contact: Angel Montejo-Gonzalez, M.D.    34 639-754-620    amontejo@usal.es   
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Jose Miguel Lainez Andres    349 61973910    miguel.lainez@sen.es   
Hospital Universitari i Politecnic La Fe Recruiting
Valencia, Spain, 46026
Contact: Miguel Baquero Toledo, M.D.    34 667-7034    miquelbaquero@gmail.com   
Hospital Universitario Rio Hortega Recruiting
Valladolid, Spain, 47012
Contact: Juan Luis Muñoz Sanchez    346 51573536    jlmusa@icloud.com   
Complejo Asistencial de Zamora Recruiting
Zamora, Spain, 49021
Contact: Manuel Franco Martin, M.D.    34 651 573 536    mfm@intras.es   
Ukraine
I.I. Mechnikov - Dnipropetrovsk Regional Clinical Hospital Recruiting
Dnipro, Ukraine, 49005
Contact: Svitlana Moroz    380 675658914    psomoroz@gmail.com   
Kiev City Psychoneurological hospital # 3 Recruiting
Hlevakha, Ukraine, 08631
Contact: Iryna Vrublesvska    380 445122457    vrublevskaya71@ukr.net   
Kharkiv Regional Clinical Psychiatric Hospital No. 3, #23 Recruiting
Kharkiv, Ukraine, 61068
Contact: Andriy Dubenko, M.D.    380503002321    adneuro1801@gmail.com   
Kharkiv Regional Council "Regional Clinical Psychiatric Hospital No. 3, #14 Recruiting
Kharkiv, Ukraine, 61068
Contact: Valentyna Kozidubova, M.D.    3800954735838    valentinakozidubova@gmail.com   
Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine Recruiting
Kharkiv, Ukraine, 64068
Contact: Valerii Pidkorytov    380 506834133    pid-vs@ukr.net   
Kherson Regional Psychiatric Hospital Recruiting
Kherson, Ukraine, 73488
Contact: Pavlo Palamarchuk, M.D.    380-504940457    pavel.palamarchuk@mental.kherson.ua   
Kyiv Center for Novel Treatment and Rehabilitation of Phychotic disorders Recruiting
Kyiv, Ukraine, 4080
Contact: Yuliya Blazhevych, M.D.    380503847048    blazhevych@ukr.net   
Lviv Regional Clinical Psychiatric Hospital Recruiting
Lviv, Ukraine, 79021
Contact: Kateryna Zakal, M.D.    00380677612919    katerynaz97@gmail.com   
Poltava Regional Clinical Psychiatric Hospital named after O.F. Maltsev Recruiting
Poltava, Ukraine, 36013
Contact: Andrii Skrypnikov, M.D.    380 50 252 33 00    skripnikovan@mail.ru   
Acad. O. I. Iushchenko - Vinnitsia Regional Psychoneurologic Hospital Recruiting
Vinnytsia, Ukraine, 21005
Contact: Oksana Serebrennikova    380 679605672    oserebrennikova1@gmail.com   
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03548584     History of Changes
Other Study ID Numbers: 331-14-213
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Agitation

Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents