Trials Sponsors Conditions Drugs Pricing

Conditions

Agitation Associated With Alzheimer's Disease Alzheimer's Type Mental Disorder Nervous System Diseases

Keywords

OPC-34712brexpiprazoleDementiaAlzheimer's DiseaseCognitive DisordersAgitation

Outcome Measures

Primary Outcomes (1)

Change From Baseline to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score
The CMAI is widely used in clinical research for evaluation of agitation associated with Alzheimer's dementia, with reliability and validity in both institutionalized and noninstitutionalized participants. It consists of 29 items, all rated on a 1 to 7 scale (1=Never and 7=Several times in an hour), with 1 being the "best" rating and 7 being the "worst" rating. The total score is the sum of ratings for all 29 items. The possible total scores range from 29 to 203. The total score will be unevaluable if less than 24 of the 29 items are recorded. If 24 to 28 of the 29 items are recorded, the total score will be the mean of the recorded items multiplied by 29 and rounded to the first decimal place. The mean change from baseline (Day 0) to week 12 in the CMAI total score is reported. Statistical comparison of interest was brexpiprazole flexible dose versus placebo, analyzed using a mixed-effect model repeated measure approach. A decrease in score indicates improvement in symptoms.
From screening to week 12/early termination

Secondary Outcomes (1)

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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Matching Placebo Once-Daily

Drug: Brexpiprazole, OPC-34712

Brexpiprazole (flexible dose range 0.5 to 2 mg)

EXPERIMENTAL

Titrate up from 0.25 mg/day brexpiprazole to 1 mg/day brexpiprazole. After achieving 1 mg/day target dose may be increased or decreased based on efficacy and tolerability. Allowable flexible doses will be 0.5 mg/day, 1 mg/day, or 2 mg/day.

Drug: Brexpiprazole, OPC-34712

Interventions

Brexpiprazole, OPC-34712Drug

Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks

Brexpiprazole (flexible dose range 0.5 to 2 mg)Placebo

Eligibility Criteria

Age55 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

H. Lundbeck A/S
Industrycollaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industrylead

Study Sites (70)

Imperial, California, 92251, United States

Lakewood, California, 08755, United States

Long Beach, California, 90806, United States

Long Beach, California, 90822, United States

Panorama City, California, 91402, United States

Universal City, California, 91950, United States

Denver, Colorado, 80209, United States

Related Publications (6)

Porsteinsson AP, Chumki SR, Wang D, Such P, Palma AM, Zhang Z, Shah A, Kalu U, Montano CB. Short-Term and Long-Term Safety Analyses of Brexpiprazole for Agitation Associated with Dementia due to Alzheimer's Disease: Timing and Duration of Adverse Events. Drug Saf. 2026 Aug;49(8):969-983. doi: 10.1007/s40264-026-01670-w. Epub 2026 Apr 10.
PMID: 41961243DERIVED
Cummings JL, Chumki SR, Chang D, Zhang Z, Brubaker M, Hefting N, Such P, Wang D, Grossberg GT. Efficacy of Brexpiprazole in Participants with Agitation Associated with Dementia Due to Alzheimer's Disease: Pooled Analysis of Randomized Controlled Trials. Clin Drug Investig. 2026 Mar;46(3):281-292. doi: 10.1007/s40261-025-01517-9. Epub 2026 Jan 27.
PMID: 41591746DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseMental DisordersNervous System DiseasesDementiaCognitive DysfunctionPsychomotor Agitation

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersCognition DisordersDyskinesias

Results Point of Contact

Title: Global Clinical Development
Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Officials

Eva Koheygi, MD
Otsuka Pharmaceutical Development & Commercialization, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

270 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 14, 2013

Study Start

September 2013

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Placebo

Brexpiprazole (flexible dose range 0.5 to 2 mg)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (70)

Related Publications (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Placebo

Brexpiprazole (flexible dose range 0.5 to 2 mg)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (70)

Related Publications (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations