CompletedPhase 3Results posted

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses 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

433

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks

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 ID331-12-283

NCT IDNCT01862640

Timeline

Milestones

Study first posted2013-05-24estimated

Study start2013-07-11actual

Primary completion2017-03-15actual

Study completion2017-03-15actual

Results first posted2020-06-16actual

Last update posted2020-12-31actual

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 participants 55 to 90 years of age, inclusive, at the time of informed consent.

•Participants 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.

•Participants with a diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association.

•Participants with a Mini-Mental State Exam score of 5 to 22, inclusive, at screening and baseline visits.

•Participants with onset of symptoms of agitation at least 2 weeks prior to the screening visit.

•Participants with a score of ≥ 4 on the agitation/aggression item of the Neuropsychiatric Inventory-Nursing Home at the screening and baseline visits.

•Participants who require pharmacotherapy for treatment of agitation per the investigator's judgment, after an evaluation for reversible factors (for example, pain, infection, polypharmacy) and a trial of nonpharmacological intervention.

•Participants must have a previous magnetic resonance imaging or computed tomography 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

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

•Participants with a history of stroke, well-documented transient ischemic attack, pulmonary or cerebral embolism.

•Participants who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.

•Participants who have been diagnosed with an Axis I disorder (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision criteria)

•Participants with uncontrolled hypertension

•Participants with uncontrolled insulin-dependent diabetes mellitus

•Participants with epilepsy or a history of seizures

•Participants 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 In The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks Of Brexpiprazole Treatment

Time frame:Baseline, Week 12/Early Termination (ET)

change from baseline, improvement

Primary/registry result

Change From Baseline In The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks Of Brexpiprazole Treatment

Time frame:Baseline, Week 12/Early Termination (ET)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), units on a scale	Standard error
Brexpiprazole 2 mg/Dayn=138 Participants	-21.6	1.32
Brexpiprazole 1 mg/Dayn=134 Participants	-17.6	1.33
Placebon=131 Participants	-17.8	1.34

Least square (LS) mean difference-3.7795% CI-7.38 - -0.17p=0.0404Mixed-effect model repeated measure

LS mean difference0.2395% CI-3.40 - 3.86p=0.9015Mixed-effect model repeated measure

Secondary/protocol endpoint

Change From Baseline In The Clinical Global Impression-Severity Of Illness (CGI-S) Score, As Related To Symptoms Of Agitation After 12 Weeks Of Brexpiprazole Treatment

Time frame:Baseline, Week 12/ET

change from baseline, improvement

Secondary/registry result

Change From Baseline In The Clinical Global Impression-Severity Of Illness (CGI-S) Score, As Related To Symptoms Of Agitation After 12 Weeks Of Brexpiprazole Treatment

Time frame:Baseline, Week 12/ET

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Brexpiprazole 2 mg/Dayn=138 Participants	-1.29	1.05
Brexpiprazole 1 mg/Dayn=134 Participants	-1.04	1.12
Placebon=131 Participants	-1.08	0.89

LS mean difference-0.1695% CI-0.39 - 0.06p=0.1566Mixed-effect model repeated measure

LS mean difference0.0995% CI-0.14 - 0.32p=0.4440Mixed-effect model repeated measure

Publications (10)

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.