A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03548584|
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : June 30, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Agitation Associated With Alzheimer's Dementia Alzheimer Dementia||Drug: Brexpiprazole Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||345 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type|
|Actual Study Start Date :||May 16, 2018|
|Actual Primary Completion Date :||May 23, 2022|
|Actual Study Completion Date :||June 1, 2022|
Experimental: Low Dose Brexpiprazole Arm
Other Name: OPC-34712
Experimental: High Dose Brexpiprazole Arm
Other Name: OPC-34712
Placebo Comparator: Placebo
- Cohen-Mansfield Agitation Inventory (CMAI) total score [ Time Frame: From baseline to week 12 visit ]Change from baseline to Week 12; assesses frequency of agitated behaviors in elderly persons. The scale consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. Each of the agitated behaviors are scored 1 (never) to 7 (several times an hours), with the total scale score ranging from 29 to 203. The higher the value, the more frequent an agitated behavior has occurred.
- Clinical Global Impression Severity of Illness (CGI-S) score [ Time Frame: From baseline to week 12 visit ]Change from baseline to week 12, as related to agitation. CGI-S will be used to rate the severity of agitation. Score ranges from 0 (not assessed) to 7 (among the most extremely ill subjects). The higher the value, the more severe the agitation.
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|Ages Eligible for Study:||55 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects with a diagnosis of probable Alzheimer's disease.
- Subjects with a diagnosis of agitation
- Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.
- Subjects 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.
- Subjects 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 subjects with an identified caregiver who has sufficient contact (minimum of 2 hours per day for 4 days per week) to describe the subject's symptoms and has direct observation of the subject's behavior. Non-institutionalized subjects 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 subject's symptoms and has direct observation of the subject's behavior.
- Subjects with onset of symptoms of agitation at least 2 weeks prior to screening visit.
- Subjects will and able to discontinue all prohibited concomitant medications to meet protocol required washouts prior to and during the trial period.
- Subjects with dementia or other memory impairment not due to Alzheimer's disease.
- Subjects with a history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.
- Subjects who had an insufficient response, based on the investigator's judgment, to 2 or more previous antipsychotic medications.
- Subjects who have been diagnosed with an Axis I disorder.
- Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
- Subjects with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension.
- Subjects with diabetes mellitus (insulin-dependent and non-insulin-dependent) may be eligible for the trial if their condition is stable and well-controlled.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548584
|United States, California|
|For additional information regarding sites, contact 844-687-8522|
|Los Angeles, California, United States, 90036|
|Responsible Party:||Otsuka Pharmaceutical Development & Commercialization, Inc.|
|Other Study ID Numbers:||
|First Posted:||June 7, 2018 Key Record Dates|
|Last Update Posted:||June 30, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.|
|Access Criteria:||Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs