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

Study Identifier:
331-14-213
ClinicalTrials.gov Identifier:
NCT03548584
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Results Availables

Study Protocol
Available Language: English
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Statistical Analysis Plan
Available Language: English
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Study Details

Medical Condition
  • Dementia/Alzheimer
Study Drug
  • Drug: Brexpiprazole
Date
May 2018 - May 2022
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 55 - 90 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Participants with a diagnosis of probable Alzheimer's disease.
  • Participants with a diagnosis of agitation
  • Participants with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.
  • Participants 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.
  • Participants 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 participants with an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the participant's symptoms and has direct observation of the participant's behavior. Non-institutionalized participants 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 participant's symptoms and has direct observation of the participant's behavior.
  • Participants with onset of symptoms of agitation at least 2 weeks prior to screening visit.
  • Participants will and able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period.
Exclusion Criteria
  • Participants with dementia or other memory impairment not due to Alzheimer's disease.
  • Participants with a history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.
  • Participants who had an insufficient response, based on the investigator's judgment, to 2 or more previous antipsychotic medications.
  • Participants who have been diagnosed with an Axis I disorder.
  • Participants who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
  • Participants with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension.
  • Participants with diabetes mellitus (insulin-dependent and non-insulin-dependent) may be eligible for the trial if their condition is stable and well-controlled.

Protocol Summary

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

Study Locations

Location
Status
Location
For additional information regarding sites, contact 844-687-8522
Los Angeles, California, United States, 90036
Status
N/A
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Participants with a diagnosis of probable Alzheimer's disease.
  • Participants with a diagnosis of agitation
  • Participants with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.
  • Participants 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.
  • Participants 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 participants with an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the participant's symptoms and has direct observation of the participant's behavior. Non-institutionalized participants 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 participant's symptoms and has direct observation of the participant's behavior.
  • Participants with onset of symptoms of agitation at least 2 weeks prior to screening visit.
  • Participants will and able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period.
Exclusion criteria
  • Participants with dementia or other memory impairment not due to Alzheimer's disease.
  • Participants with a history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.
  • Participants who had an insufficient response, based on the investigator's judgment, to 2 or more previous antipsychotic medications.
  • Participants who have been diagnosed with an Axis I disorder.
  • Participants who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
  • Participants with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension.
  • Participants with diabetes mellitus (insulin-dependent and non-insulin-dependent) may be eligible for the trial if their condition is stable and well-controlled.

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