NCT06875986

REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate safety of REXULTI in patients under daily clinical settings. In addition, information on efficacy will be collected.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Brexpiprazole (Rexulti)	In general, for adults, start with taking 0.5 mg of brexpirazole at a time, once a day. Then the dose will be increased with an interval of at least one week to 1 mg at a time, once a day. If you have no problem with tolerability and do not show an adequate response, the dose may be increased to 2 mg at a time, once a day, but the increase should be made at intervals of at least one week.

Timeline

• Start date: 2025-04-17
• Primary completion: 2027-09-30
• Completion: 2028-09-23
• First posted: 2025-03-14
• Last updated: 2025-07-02

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study