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

NCT03620981 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2024-11-14

Study results available
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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

Interventions

DRUG

Brexpiprazole

Drug: 1 tablet /day Once daily for 10 weeks

DRUG

Placebo

Placebo: 1 tablet /day Once daily for 10 weeks

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2023-04-21
Completion
2023-05-15

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03620981 on ClinicalTrials.gov