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

Sponsor ID
331-14-213
Clinicaltrials.gov ID
NCT03548584
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
331-14-213
Trial Details
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Age
55 - 90 Years
Therapeutic Area
  • Dementia/Alzheimer
    • Sex
    Female & Male
    Trial Dates
    May 2018 - May 2022
    Healthy Volunteers
    No
    • 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.
    • 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.

    Study 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.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Brexpiprazole
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    345
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Participants with a diagnosis of probable Alzheimer's disease.
    • * Participants with a diagnosis of agitation

    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.
    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.

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    For additional information regarding sites, contact 844-687-8522
    Los Angeles, California, United States, 90036
    Status
    N/A

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