Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

NCT03620981 | Completed Phase 2 Results DMC

• 1 other identifier: 331-102-00088
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the safety of brexpiprazole and identify the optimum dose.

Conditions

Agitation Associated With Dementia of the Alzheimer's Type

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.

  The CMAI assessed the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consisted 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 was 29, and the maximum possible CMAI total score was 203. A decrease in score indicated improvement in symptoms.

  Baseline and 10 weeks first dose, on average 10 weeks

Secondary Outcomes (2)

• Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.

  Baseline and 10 weeks first dose, on average 10 weeks

• Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.

  Baseline and 10 weeks first dose, on average 10 weeks

Study Arms (3)

Brexpiprazole, 1mg/day

EXPERIMENTAL

Drug: 1mg/day Once daily for 10 weeks

Drug: Brexpiprazole

Brexpiprazole, 2mg/day

EXPERIMENTAL

Drug: 2mg/day Once daily for 10 weeks

Drug: Brexpiprazole

Placebo

PLACEBO COMPARATOR

Drug: Placebo (0mg/day) Once daily for 10 weeks

Drug: Placebo

Interventions

Brexpiprazole DRUG

Drug: 1 tablet /day Once daily for 10 weeks

Brexpiprazole, 1mg/day; Brexpiprazole, 2mg/day

Placebo DRUG

Placebo: 1 tablet /day Once daily for 10 weeks

Placebo

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who satisfy both of the following diagnostic criteria:
• Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-5.
• Diagnosis of "Probable Alzheimer's Disease" according to NINCDS-ADRDA.
• Hospitalized patients or care facility patients or care at home patients
• Patients with an MMSE score of 1 to 22
• Patients who have the agitation defined according to the "Consensus provisional definition of agitation in cognitive disorders" from the International Psychogeriatric Association (IPA)

You may not qualify if:

• Patients who have dementia other than dementia of the Alzheimer's type
• Patients diagnosed with delirium between 30 days before the screening examination and baseline evaluation according to DSM-5.
• Patients diagnosed with any of the following disorders according to DSM-5:
• Schizophrenia spectrum and other psychotic disorders
• Bipolar and related disorders
• Major depressive disorder

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Jisenkai Nanko Psychiatric Institute

Shirakawa, Japan

Location

Related Publications (1)

• Nakamura Y, Adachi J, Hirota N, Iba K, Sasajima C, Shimizu K, Nakai M, Takahashi K. Brexpiprazole's impacts on patients and caregivers in agitation in Alzheimer's dementia. Alzheimers Dement. 2025 Jul;21(7):e70522. doi: 10.1002/alz.70522.

  PMID: 40717666 DERIVED

MeSH Terms

Interventions

brexpiprazole

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., Ltd.

CL_OPCJ_RDA_Team@otsuka.jp

06-6943-7722

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• 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 5, 2018
• First Posted: August 8, 2018
• Study Start: August 20, 2018
• Primary Completion: April 21, 2023
• Study Completion: May 15, 2023
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• 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 an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

JP (1)