Alzheimer DiseaseNCT06875986
REXULTI General Use Results Survey in Patients With Hyperactivity, or Aggressive Behavior Associated With Alzheimer's Dementia
An observational study of Alzheimer Disease, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Brexpiprazole (Rexulti)
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- 17 Apr 2025to 23 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in Japan who are planned to be newly started on Brexpiprazole OD tablets therapy for the 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
Who may be able to join
- Patients diagnosed with Alzheimer's disease
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd contact
Japan1 site, 1 recruiting
- Recruiting
Pharmacovigilance Department
Osaka, 540-0021
Study Director, +81-6-6943-7722, komaniwa.satoshi@otsuka.jp
About this study
Official title: 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)
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
- Being tested
- Brexpiprazole (Rexulti)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brexpiprazole (Rexulti)Drug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Information (Adverse Event)
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 (brexpiprazole), whether or not it is considered causally related to the Medicinal Product.
Measured: 24 weeks from the initiation of brexpiprazole treatment
Safety Information (Special Situations)
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
Measured: 24 weeks from the initiation of brexpiprazole treatment
Safety Information (Number of off-Label Use)
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.
Measured: 24 weeks from the initiation of brexpiprazole treatment
Safety Information (Serious Adverse Event)
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.
Measured: 24 weeks from the initiation of brexpiprazole treatment
Safety Information (Non-serious Adverse Events)
All Adverse Events that do not meet the definition of a serious Adverse Event are considered non-serious Adverse Events.
Measured: 24 weeks from the initiation of brexpiprazole treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start17 Apr 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion23 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875986
- Sponsor's protocol ID
- 331-101-00612
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06875986
- Acronym / sponsor ID
- 331-101-00612
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 23 Sep 2028 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in Japan who are planned to be newly started on Brexpiprazole OD tablets therapy for the 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
Key inclusion criteria (1 listed)
- Patients diagnosed with Alzheimer's disease
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | – |
Primary outcome
Safety Information (Adverse Event)
Time frame: 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 (brexpiprazole), whether or not it is considered causally related to the Medicinal Product.
Safety Information (Special Situations)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Related trials for Alzheimer Disease
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Active, not recruiting
Promoting Physical Activity in Older Hispanic/Latino(a) Adults
Sedentary Behavior, Physical Inactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pharmacovigilance Department Otsuka Pharmaceutical Co., Ltd (+81-6-6943-7722, komaniwa.satoshi@otsuka.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Information (Adverse Event) (time frame: 24 weeks from the initiation of brexpiprazole treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.