A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation
NCT ID: NCT01862640
Last Updated: 2020-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
433 participants
INTERVENTIONAL
2013-07-11
2017-03-15
Brief Summary
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Detailed Description
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This is a trial designed to assess the safety and efficacy of brexpiprazole in the treatment of participants with agitation associated with dementia of the Alzheimer's Type. The trial consists of a continuous 12-week double-blind treatment period with a 30-day follow-up. The trial population will include male and female participants 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 participant is not living alone.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Matching placebo once daily
Placebo Oral Tablet
Once-daily, tablets
Brexpiprazole 1 mg
Titrate up from 0.25 milligrams (mg)/day brexpiprazole to 1 mg/day brexpiprazole
Brexpiprazole, OPC-34712
Once-daily, tablets
Brexpiprazole 2 mg
Titrate up from 0.25 mg/day brexpiprazole to 2 mg/day brexpiprazole
Brexpiprazole, OPC-34712
Once-daily, tablets
Interventions
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Brexpiprazole, OPC-34712
Once-daily, tablets
Placebo Oral Tablet
Once-daily, tablets
Eligibility Criteria
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Inclusion Criteria
* Participants who are residing at their current location for at least 14 days before screening and are expected to remain at the same location for the duration of the trial.
* Participants with a diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association.
* Participants with a Mini-Mental State Exam score of 5 to 22, inclusive, at screening and baseline visits.
* Participants with onset of symptoms of agitation at least 2 weeks prior to the screening visit.
* Participants with a score of ≥ 4 on the agitation/aggression item of the Neuropsychiatric Inventory-Nursing Home at the screening and baseline visits.
* Participants who require pharmacotherapy for treatment of agitation per the investigator's judgment, after an evaluation for reversible factors (for example, pain, infection, polypharmacy) and a trial of nonpharmacological intervention.
* Participants must have a previous magnetic resonance imaging or computed tomography of the brain, which was performed after the onset of symptoms of dementia, with findings consistent with the diagnosis of Alzheimer's disease.
Exclusion Criteria
* Participants with a history of stroke, well-documented transient ischemic attack, pulmonary or cerebral embolism.
* Participants who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
* Participants who have been diagnosed with an Axis I disorder (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision criteria)
* Participants with uncontrolled hypertension
* Participants with uncontrolled insulin-dependent diabetes mellitus
* Participants with epilepsy or a history of seizures
* Participants considered in poor general health based on the investigator's judgment.
55 Years
90 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Eva Kohegyi, MD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations
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Tuscaloosa, Alabama, United States
Phoenix, Arizona, United States
Bellflower, California, United States
Costa Mesa, California, United States
Downey, California, United States
Orange, California, United States
Redlands, California, United States
Yorba Linda, California, United States
Norwalk, Connecticut, United States
Coconut Creek, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Lauderhill, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Springs, Florida, United States
Sarasota, Florida, United States
Decatur, Georgia, United States
Suwanee, Georgia, United States
Weymouth, Massachusetts, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Mount Arlington, New Jersey, United States
Paterson, New Jersey, United States
Toms River, New Jersey, United States
Hickory, North Carolina, United States
Oklahoma City, Oklahoma, United States
Franklin, Tennessee, United States
Bedford, Texas, United States
Waukesha, Wisconsin, United States
Rijeka, , Croatia
Zadar, , Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Mittweida, Saxony, Germany
Achim, , Germany
Berlin, , Germany
Bielefeld, , Germany
Bochum, , Germany
Cologne, , Germany
Hamburg, , Germany
Ostfildern, , Germany
Westerstede, , Germany
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Saratov, , Russia
Tonnel'nyy, , Russia
Yekaterinburg, , Russia
Belgrade, , Serbia
Kovin, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Novi Kneževac, , Serbia
Novi Sad, , Serbia
Vršac, , Serbia
Barcelona, , Spain
Getafe, , Spain
Girona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Pamplona, , Spain
Salamanca, , Spain
Valencia, , Spain
Valencia, , Spain
Zamora, , Spain
Kharkiv, , Ukraine
Kherson, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Odesa, , Ukraine
Poltava, , Ukraine
Countries
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References
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Stroud J, Cummings JL, Chumki SR, Such P, Wang D, Palma AM, Zhang Z, Brubaker M, Grossberg GT. Brexpiprazole for agitation in clinically relevant patient subgroups: a post hoc analysis of efficacy and safety in patients with agitation associated with dementia due to Alzheimer's disease. Curr Med Res Opin. 2025 Sep 5:1-12. doi: 10.1080/03007995.2025.2552278. Online ahead of print.
Shah A, Estilo A, Sheridan PL, Kalu U, Chen D, Chang D, Slomkowski M, Lee D, Hefting N, Hobart M, Behl S, Such P, Brubaker M, Grossberg GT. Safety and Tolerability of Brexpiprazole in Participants with Agitation Associated with Dementia due to Alzheimer's Disease: Pooled Analysis of Three Randomized Trials and an Extension Trial. CNS Drugs. 2025 Oct;39(10):1011-1023. doi: 10.1007/s40263-025-01200-9. Epub 2025 Jul 19.
Meunier J, Creel K, Loubert A, Larsen KG, Aggarwal J, Hefting N, Oberdhan D. Defining a clinically meaningful within-patient change threshold for the Cohen-Mansfield Agitation Inventory in Alzheimer's dementia. Front Neurol. 2024 Jul 23;15:1379062. doi: 10.3389/fneur.2024.1379062. eCollection 2024.
Grossberg GT, Kohegyi E, Mergel V, Josiassen MK, Meulien D, Hobart M, Slomkowski M, Baker RA, McQuade RD, Cummings JL. Efficacy and Safety of Brexpiprazole for the Treatment of Agitation in Alzheimer's Dementia: Two 12-Week, Randomized, Double-Blind, Placebo-Controlled Trials. Am J Geriatr Psychiatry. 2020 Apr;28(4):383-400. doi: 10.1016/j.jagp.2019.09.009. Epub 2019 Oct 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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331-12-283
Identifier Type: -
Identifier Source: org_study_id