Recruiting 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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brexpiprazole (Rexulti).
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Safety Information (Adverse Event) [Time frame: 24 weeks from the initiation of brexpiprazole treatment]
- Safety Information (Special Situations) [Time frame: 24 weeks from the initiation of brexpiprazole treatment]
- Safety Information (Number of off-Label Use) [Time frame: 24 weeks from the initiation of brexpiprazole treatment]
- Safety Information (Serious Adverse Event) [Time frame: 24 weeks from the initiation of brexpiprazole treatment]
- Safety Information (Non-serious Adverse Events) [Time frame: 24 weeks from the initiation of brexpiprazole treatment]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with Alzheimer's disease
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Pharmacovigilance Department — Osaka
Identifiers
NCT: NCT06875986 · 331-101-00612