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)

NCT ID: NCT06875986

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-17

Study Completion Date

2028-09-23

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with Alzheimer's disease

Exclusion Criteria

\-
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pharmacovigilance Department

Osaka, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd

Role: CONTACT

+81-6-6943-7722

Facility Contacts

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Study Director

Role: primary

+81-6-6943-7722

Other Identifiers

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331-101-00612

Identifier Type: -

Identifier Source: org_study_id

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