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 In The Cohen-Mansfield Agitation Inventory (CMAI) Total Score After 12 Weeks Of Brexpiprazole Treatment
To compare the efficacy of 2 fixed doses (1 mg/day and 2 mg/day) of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type, by the assessment of CMAI after 12 weeks of treatment. The CMAI assesses the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consists of 29 items all rated on a 1 to 7 scale with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score is 29, and the maximum possible CMAI total score is 203. A decrease in score indicates improvement in symptoms. To control the overall type I error at 0.05 level when making 2 comparisons of brexpiprazole doses versus placebo, statistical testing was carried out using a hierarchical testing procedure in the order of: 1) comparison of 2 mg/day brexpiprazole versus placebo, and 2) comparison of 1 mg/day brexpiprazole versus placebo.
Baseline, Week 12/Early Termination (ET)

Secondary Outcomes (1)

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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Matching placebo once daily

Drug: Placebo Oral Tablet

Brexpiprazole 1 mg

EXPERIMENTAL

Titrate up from 0.25 milligrams (mg)/day brexpiprazole to 1 mg/day brexpiprazole

Drug: Brexpiprazole, OPC-34712

Brexpiprazole 2 mg

EXPERIMENTAL

Titrate up from 0.25 mg/day brexpiprazole to 2 mg/day brexpiprazole

Drug: Brexpiprazole, OPC-34712

Interventions

Brexpiprazole, OPC-34712Drug

Once-daily, tablets

Brexpiprazole 1 mgBrexpiprazole 2 mg

Placebo Oral TabletDrug

Once-daily, tablets

Placebo

Eligibility Criteria

Age55 Years - 90 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

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.

Sponsors & Collaborators

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

Study Sites (85)

Tuscaloosa, Alabama, 35404, United States

Phoenix, Arizona, 85013, United States

Bellflower, California, 90706, United States

Costa Mesa, California, 92627, United States

Downey, California, 90706, United States

Orange, California, 92868, United States

Redlands, California, 92373, United States

Related Publications (12)

Porsteinsson AP, Chumki SR, Palma AM, Zhang Z, Wang D, Such P, Montano CB. Brexpiprazole for Individual Agitation Symptoms in Alzheimer's Dementia: A Caregiver-Centered Post Hoc Analysis. Neurol Ther. 2026 Oct 16. doi: 10.1007/s40120-026-01037-4. Online ahead of print.
PMID: 42888370DERIVED
Montano CB, Chumki SR, Wang D, Palma AM, Zhang Z, Porsteinsson AP. Brexpiprazole With Antidepressants for Agitation in Alzheimer's Dementia: Post Hoc Analysis. Am J Geriatr Psychiatry. 2026 Jun 30:S1064-7481(26)00450-1. doi: 10.1016/j.jagp.2026.06.015. Online ahead of print.
PMID: 42502037DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseMental DisordersNervous System DiseasesDementiaCognitive DysfunctionPsychomotor Agitation

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersCognition DisordersDyskinesias

Limitations and Caveats

None reported

Results Point of Contact

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

Study Officials

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

Publication Agreements

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

Enrollment

433 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

May 22, 2013

First Posted

May 24, 2013

Study Start

July 11, 2013

Actual (reported)

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 (3)

Placebo

Brexpiprazole 1 mg

Brexpiprazole 2 mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (85)

Related Publications (12)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

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