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)

Recruiting

• Conditions: Alzheimer Disease

• Registration Number: NCT06875986
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-14
• Study Start: 2025-04-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-09-30
• Study Completion: 2028-09-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients diagnosed with Alzheimer's disease

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Information (Adverse Event)	24 weeks from the initiation of brexpiprazole treatment	Any untoward medicinal occurrence in a patient or clinical study subject administered a Medicinal Product and which does not necessarily have a causal relationship with this treatment (ICH-E2A Guideline). An Adverse Event can therefore be any unfavorable and unintended sign (e.g. abnormal laboratory finding), symptom, or disease temporally associated with the use of a Medicinal Product (Samsca), whether or not it is considered causally related to the Medicinal Product.
Safety Information (Special Situations)	24 weeks from the initiation of brexpiprazole treatment	Situations related to the use of an Otsuka product which may or may not be associated with an adverse event: -Maternal (pregnancy and breastfeeding) or paternal (via semen) exposure; -Exposure during breastfeeding; -Overdose/Incorrect dosage, misuse, abuse (e.g. patient sharing products); -Medication errors (e.g. patient took wrong dose); -Lack of therapeutic efficacy (e.g. the product doesn't work); -Occupational exposure (e.g.: nurse administering the product is exposed); -Cases of suspected transmission of infectious agents; -Use of suspected or confirmed falsified product(s) or quality defect of the product(s); -Withdrawal reactions; -Accidental exposure (e.g.: child takes parent's product); -Drug-drug/drug-food interactions; -Unintentional use of product in a non-approved population (e.g.: pediatric or geriatric population); -Disease progression/exacerbation of existing disease
Safety Information (Number of off-Label Use)	24 weeks from the initiation of brexpiprazole treatment	Collecting any type of off-Label Use that refers to situations where a product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use also includes the intentional use in non-authorized population categories not indicated in the label.
Safety Information (Serious Adverse Event)	24 weeks from the initiation of brexpiprazole treatment	Any adverse drug experience/event occurring at any dose which -results in death -is life-threatening -requires inpatient hospitalization or prolonged of existing hospitalization -results in persistent or significant disability or incapacity -is a congenital anomaly/birth defect -is medically significant.
Safety Information (Non-serious Adverse Events)	24 weeks from the initiation of brexpiprazole treatment	All Adverse Events that do not meet the definition of a serious Adverse Event are considered non-serious Adverse Events.

Trial Locations

Locations (1)

Pharmacovigilance Department; 🇯🇵 Osaka, Japan