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To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the safety of brexpiprazole and identify the optimum dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brexpiprazole, 1mg/day | Experimental | Drug: 1mg/day Once daily for 10 weeks |
|
| Brexpiprazole, 2mg/day | Experimental | Drug: 2mg/day Once daily for 10 weeks |
|
| Placebo | Placebo Comparator | Drug: Placebo (0mg/day) Once daily for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole | Drug | Drug: 1 tablet /day Once daily for 10 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing. | The CMAI assessed the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consisted of 29 items all rated on a 1 to 7 scale with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score was 29, and the maximum possible CMAI total score was 203. A decrease in score indicated improvement in symptoms. | Baseline and 10 weeks first dose, on average 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing. | The CGI-S was used to rate the severity of agitation. Scores were: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. A decrease in score indicated improvement in symptoms. |
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Inclusion Criteria:
Patients who satisfy both of the following diagnostic criteria:
Hospitalized patients or care facility patients or care at home patients
Patients with an MMSE score of 1 to 22
Patients who have the agitation defined according to the "Consensus provisional definition of agitation in cognitive disorders" from the International Psychogeriatric Association (IPA)
Exclusion Criteria:
Patients who have dementia other than dementia of the Alzheimer's type
Patients diagnosed with delirium between 30 days before the screening examination and baseline evaluation according to DSM-5.
Patients diagnosed with any of the following disorders according to DSM-5:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jisenkai Nanko Psychiatric Institute | Shirakawa | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40717666 | Derived | Nakamura Y, Adachi J, Hirota N, Iba K, Sasajima C, Shimizu K, Nakai M, Takahashi K. Brexpiprazole's impacts on patients and caregivers in agitation in Alzheimer's dementia. Alzheimers Dement. 2025 Jul;21(7):e70522. doi: 10.1002/alz.70522. |
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Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
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Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brexpiprazole 1 mg | Participants received a brexpiprazole 0.5 mg tablet once daily for 1 week followed by a 1 mg tablet once daily for 9 weeks. |
| FG001 | Brexpiprazole 2 mg | Participants received a brexpiprazole 0.5 mg tablet once daily for the first week, followed by a 1 mg tablet once daily for the second week, and then, subsequently, a 2 mg tablet once daily for the following 8 weeks. |
| FG002 | Placebo | Participants received placebo tablet once daily for 10 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brexpiprazole 1 mg | Participants received a brexpiprazole 0.5 mg tablet once daily for 1 week followed by a 1 mg tablet once daily for 9 weeks. |
| BG001 | Brexpiprazole 2 mg | Participants received a brexpiprazole 0.5 mg tablet once daily for the first week, followed by a 1 mg tablet once daily for the second week, and then, subsequently, a 2 mg tablet once daily for the following 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing. | The CMAI assessed the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consisted of 29 items all rated on a 1 to 7 scale with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score was 29, and the maximum possible CMAI total score was 203. A decrease in score indicated improvement in symptoms. | The full analysis set (FAS) comprised subjects who, after randomization, have received at least 1 dose of the IMP, and from whom CMAI total scores have been obtained at baseline and at least 1 time point after initiation of the treatment. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 10 weeks first dose, on average 10 weeks |
|
Adverse events were monitored from signing of the informed consent form until follow-up for up to 35 days after the final day of IMP administration, on average 19 weeks
The safety analysis comprised subjects who, after randomization, have received at least 1 dose of the IMP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brexpiprazole 1 mg | Participants received a brexpiprazole 0.5 mg tablet once daily for 1 week followed by a 1 mg tablet once daily for 9 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., Ltd. | 06-6943-7722 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2022 | Apr 10, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2023 | Apr 10, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
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| Placebo | Drug | Placebo: 1 tablet /day Once daily for 10 weeks |
|
| Baseline and 10 weeks first dose, on average 10 weeks |
| Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing. | The CGI-I Scale was clinician-rated scale which assessed the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. | Baseline and 10 weeks first dose, on average 10 weeks |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Legal Representative |
|
| Withdrawal by Care Giver |
|
| Non-compliance with Study Drug |
|
| BG002 | Placebo | Participants received placebo tablet once daily for 10 weeks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Brexpiprazole 2 mg | Participants received a brexpiprazole 0.5 mg tablet once daily for the first week, followed by a 1 mg tablet once daily for the second week, and then, subsequently, a 2 mg tablet once daily for the following 8 weeks. |
| OG002 | Placebo | Participants received placebo tablet once daily for 10 weeks. |
|
|
|
| Secondary | Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing. | The CGI-S was used to rate the severity of agitation. Scores were: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. A decrease in score indicated improvement in symptoms. | Efficacy sample（FAS）consisted of all participants who have received at least 1 dose of the IMP and have Baseline and at least one Post-Baseline efficacy evaluation. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 10 weeks first dose, on average 10 weeks |
|
|
|
|
| Secondary | Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing. | The CGI-I Scale was clinician-rated scale which assessed the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition. | Efficacy sample（FAS) consisted of all participants who have received at least 1 dose of the IMP and have Baseline and at least one Post-Baseline efficacy evaluation. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 10 weeks first dose, on average 10 weeks |
|
|
|
|
| 2 |
| 112 |
| 7 |
| 112 |
| 77 |
| 112 |
| EG001 | Brexpiprazole 2 mg | Participants received a brexpiprazole 0.5 mg tablet once daily for the first week, followed by a 1 mg tablet once daily for the second week, and then, subsequently, a 2 mg tablet once daily for the following 8 weeks. | 0 | 149 | 9 | 149 | 113 | 149 |
| EG002 | Placebo | Participants received placebo tablet once daily for 10 weeks. | 0 | 149 | 7 | 149 | 93 | 149 |
| Cardiac death | General disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Hepatic mass | Hepatobiliary disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| IIIrd nerve paralysis | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Psychiatric symptom | Psychiatric disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Eye contusion | Injury, poisoning and procedural complications | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Blood prolactin increased | Investigations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Urinary occult blood positive | Investigations | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Bradykinesia | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Parkinsonian gait | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Sedation complication | Nervous system disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
| Senile xerosis | Skin and subcutaneous tissue disorders | MedDRA Ver. 25.0 | Non-systematic Assessment |
|
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| Mixed Models Analysis |
| 0.0083 |
| LS Mean Difference (Final Values) |
| -0.3 |
| 2-Sided |
| 95 |
| -0.6 |
| -0.1 |
| Superiority |
Statistical analysis to compare brexpiprazole 1 mg/day and placebo was performed at Week 10. |
| Cochran-Mantel-Haenszel |
CMH, LOCF |
| 0.0052 |
| Mean Difference (Final Values) |
| -0.5 |
| 2-Sided |
| 95 |
| -0.8 |
| -0.1 |
| Superiority |