Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
NCT ID: NCT01922258
Last Updated: 2020-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
270 participants
INTERVENTIONAL
2013-09-30
2017-03-31
Brief Summary
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Detailed Description
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This is a trial designed to assess the safety and efficacy of flexible dosing of brexpiprazole in the treatment of subjects with agitation associated with dementia of the Alzheimer's type. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching Placebo Once-Daily
Brexpiprazole, OPC-34712
Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks
Brexpiprazole (flexible dose range 0.5 to 2 mg)
Titrate up from 0.25 mg/day brexpiprazole to 1 mg/day brexpiprazole. After achieving 1 mg/day target dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day.
Brexpiprazole, OPC-34712
Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks
Interventions
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Brexpiprazole, OPC-34712
Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Subjects 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.
* Subjects with diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA criteria.
* Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.
* Subjects with onset of symptoms of agitation at least 2 weeks prior to the screening visit.
* Subjects with a total score greater than or equal to 4 on the agitation aggression item of the NPI-NH or NPI/NPI-NH at the screening and baseline visits.
* Subjects who require pharmacotherapy for the treatment of agitation per the investigator's judgement, after an evaluation of reversible factors (eg, pain, infection, polypharmacy) and a trial of nonpharmacological interventions.
* Subjects must have a previous MRI or CT scan 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
* Subjects with history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.
* Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
* Subjects who have been diagnosed with an Axis I disorder (DSM-IV-TR criteria).
* Subjects with uncontrolled hypertension.
* Subjects with uncontrolled insulin-dependent diabetes mellitus (IDDM)
* Subjects with epilepsy or a history of seizures.
* Subjects considered in poor general health based on the investigator's judgment.
55 Years
90 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eva Koheygi, MD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development and Commercialization, Inc.
Locations
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Imperial, California, United States
Lakewood, California, United States
Long Beach, California, United States
Long Beach, California, United States
Panorama City, California, United States
Universal City, California, United States
Denver, Colorado, United States
Bradenton, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orange City, Florida, United States
Atlanta, Georgia, United States
Smyrna, Georgia, United States
Honolulu, Hawaii, United States
Indianapolis, Indiana, United States
Quincy, Massachusetts, United States
South Dartmouth, Massachusetts, United States
Ann Arbor, Michigan, United States
Brooklyn, New York, United States
Buffalo, New York, United States
New Hyde Park, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Woodstock, Vermont, United States
Burgas, , Bulgaria
Kardzhali, , Bulgaria
Pazardzhik, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Veliko Tarnovo, , Bulgaria
Penticton, British Columbia, Canada
Kentville, , Canada
Kuopio, , Finland
Turku, , Finland
Bourg-en-Bresse, , France
Douai, , France
Élancourt, , France
Limoges, , France
Nice, , France
Toulouse, , France
Tonnel’nyy, Stavropol Kray, Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Yekaterinburg, , Russia
Ljubljana, , Slovenia
Maribor, , Slovenia
Šempeter pri Gorici, , Slovenia
Donetsk, , Ukraine
Kharkiv, , Ukraine
Kherson, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Poltava, , Ukraine
Simferopol, , Ukraine
Vinnytsia, , Ukraine
Crewe, , United Kingdom
Manchester, , United Kingdom
Margate, , United Kingdom
Torpoint, , United Kingdom
Countries
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References
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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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331-12-284
Identifier Type: -
Identifier Source: org_study_id