Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Last updated: November 4, 2020
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Completed

Phase

3

Condition

Alzheimer's Disease

Kleptomania

Mental Disability

Treatment

N/A

Clinical Study ID

NCT01922258
331-12-284
  • Ages 55-90
  • All Genders

Study Summary

To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female subjects 55 to 90 years of age, inclusive, at the time of informedconsent.
  • Subjects who are residing at their current location for at least 14 days beforescreening and are expected to remain at the same location for the duration of thetrial.
  • Subjects with diagnosis of probable Alzheimer's disease according to NINCDS-ADRDAcriteria.
  • 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 screeningvisit.
  • Subjects with a total score greater than or equal to 4 on the agitation aggressionitem of the NPI-NH or NPI/NPI-NH at the screening and baseline visits.
  • Subjects who require pharmacotherapy for the treatment of agitation per theinvestigator'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 afterthe onset of symptoms of dementia, with findings consistent with the diagnosis ofAlzheimer's disease.

Exclusion

Exclusion Criteria:

  • Subjects with dementia or other memory impairment not due to Alzheimer's disease.
  • Subjects with history of stroke, well-documented transient ischemic attack, orpulmonary 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.

Study Design

Total Participants: 270
Study Start date:
September 01, 2013
Estimated Completion Date:
March 31, 2017

Study Description

Behavioral symptoms, such as agitation, are core features in subjects with Alzheimer's disease and related dementias and develop in the majority of dementia subjects. The presence of agitation in subjects with Alzheimer's disease places a significant burden not only on subjects and their caregivers but also on the healthcare system.

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.

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  • Burgas, 8000
    Bulgaria

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  • Kardzhali, 6600
    Bulgaria

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  • Pazardzhik, 4400
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    Petrov, 9020
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  • Ruse, 7003
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  • Varna, 9020
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  • Veliko Tarnovo, 5000
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  • Penticton, British Columbia V2A 4M4
    Canada

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  • Kuopio, 70210
    Finland

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  • Turku, 20520
    Finland

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  • Bourg en Bresse, 01012
    France

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    France

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  • Elancourt, 78990
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  • Limoges, 87042
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  • Nice, 06100
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  • Tonnel'nyy, Stavropol Region 357034
    Russian Federation

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    Russian Federation

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    Slovenia

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    Slovenia

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    Ukraine

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  • Simferopol, 95006
    Ukraine

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  • Vinnytsia, 21005
    Ukraine

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  • Crewe, CW1 2ER
    United Kingdom

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  • Manchester, M8 5RB
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  • Margate, CT20 1JY
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  • Torpoint, PL11 2TB
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    United States

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    Panorama, California 91402
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  • Universal City, California 91950
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  • Denver, Colorado 80209
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  • Bradenton, Florida 34205
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  • Miami, Florida 33165
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  • Orange City, Florida 32763
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  • Dallas, Texas 75231
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  • Woodstock, Vermont 05091
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