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CompletedPhase 3Results posted

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

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Flexible Dosing of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Asset

Brexpiprazole

Listed sites

Recruiting sites

Enrollment

270

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 5-22

Primary endpoint

•The Cohen-Mansfield Agitation Inventory (CMAI) Total Score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID331-12-284

NCT IDNCT01922258

Timeline

Milestones

Study first posted2013-08-14estimated

Study start2013-09actual (month precision)

Primary completion2017-03actual (month precision)

Study completion2017-03actual (month precision)

Results first posted2020-07-07actual

Last update posted2020-11-20actual

Assets

Drug assets

Brexpiprazole

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male and female subjects 55 to 90 years of age, inclusive, at the time of informed consent.

•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 dementia or other memory impairment not due to Alzheimer's disease.

•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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

4 endpoints

Primary/protocol endpoint

Change From Baseline to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score

Time frame:From screening to week 12/early termination

change from baseline, improvement

Primary/registry result

Change From Baseline to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score

Time frame:From screening to week 12/early termination

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day)n=131 Participants	-18.9	1.17
Placebo (Flexible Dose Range 0.5 to 2 mg/Day)n=135 Participants	-16.5	1.13

Treatment Difference-2.3495% CI-5.49 - 0.82p=0.1454Mixed-effect model repeated measure

Secondary/protocol endpoint

Change in the Clinical Global Impression Severity of Illness (CGI-S) Score, as Related to Symptoms of Agitation

Time frame:From screening to week 12/early termination

change from baseline, improvement

Secondary/registry result

Change in the Clinical Global Impression Severity of Illness (CGI-S) Score, as Related to Symptoms of Agitation

Time frame:From screening to week 12/early termination

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Brexpiprazole (Flexible Dose Range 0.5 to 2 mg/Day)n=131 Participants	4.54	0.77
Placebo (Flexible Dose Range 0.5 to 2 mg/Day)n=135 Participants	4.51	0.74

Publications (6)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.