A Phase 2/3 interventional study of Brexpiprazole and Placebo in Agitation Associated With Dementia of the Alzheimer's Type, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 2/3, Interventional, and Treatment
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 410 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who satisfy both of the following diagnostic criteria:
Exclusion Criteria:
Patients diagnosed with any of the following disorders according to DSM-5:
Drug: 1mg/day Once daily for 10 weeks
Drug: Brexpiprazole
Drug: 2mg/day Once daily for 10 weeks
Drug: Brexpiprazole
Drug: Placebo (0mg/day) Once daily for 10 weeks
Drug: Placebo
Drug: 1 tablet /day Once daily for 10 weeks
Placebo: 1 tablet /day Once daily for 10 weeks
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.
Time frame: Baseline and 10 weeks first dose, on average 10 weeks
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.
Time frame: 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.
Time frame: Baseline and 10 weeks first dose, on average 10 weeks
| Milestone | Brexpiprazole 1 mg | Brexpiprazole 2 mg | Placebo |
|---|---|---|---|
| Started | 112 | 149 | 149 |
| Completed | 83 | 102 | 116 |
| Not completed | 29 | 47 | 33 |
| Withdrew: Adverse event | 14 | 38 | 25 |
| Withdrew: Lack of efficacy | 2 | 1 | 1 |
| Withdrew: Physician decision | 7 | 4 | 4 |
| Withdrew: Protocol violation | 1 | 2 | 1 |
| Withdrew: Withdrawal by legal representative | 2 | 1 | 1 |
| Withdrew: Withdrawal by care giver | 2 | 0 | 1 |
| Withdrew: Non-compliance with study drug | 1 | 1 | 0 |
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.
| units on a scale | Brexpiprazole 1 mg | Brexpiprazole 2 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing. | -11.7 ± 1.20 | -15.2 ± 1.05 | -8.0 ± 1.03 |
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.
| units on a scale | Brexpiprazole 1 mg | Brexpiprazole 2 mg | Placebo |
|---|---|---|---|
| Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing. | -1.0 ± 0.1 | -1.4 ± 0.09 | -0.6 ± 0.09 |
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.
| units on a scale | Brexpiprazole 1 mg | Brexpiprazole 2 mg | Placebo |
|---|---|---|---|
| Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing. | 3.1 ± 1.3 | 2.6 ± 1.2 | 3.5 ± 1.4 |
Collected over 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. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brexpiprazole 1 mg | 2/112 (1.8%) | 7/112 (6.3%) | 77/112 (68.8%) |
| Brexpiprazole 2 mg | 0/149 (0%) | 9/149 (6%) | 113/149 (75.8%) |
| Placebo | 0/149 (0%) | 7/149 (4.7%) | 93/149 (62.4%) |
| Event | Brexpiprazole 1 mg | Brexpiprazole 2 mg | Placebo |
|---|---|---|---|
| Pneumonia aspirationInfections and infestations | 2/112 | 2/149 | 0/149 |
| AgitationPsychiatric disorders | 1/112 | 0/149 | 2/149 |
| Cardiac deathGeneral disorders | 1/112 | 0/149 | 0/149 |
| Hepatic massHepatobiliary disorders | 1/112 | 0/149 | 0/149 |
| Femoral neck fractureInjury, poisoning and procedural complications | 1/112 | 1/149 | 0/149 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/112 | 1/149 | 0/149 |
| IIIrd nerve paralysisNervous system disorders | 1/112 | 0/149 | 0/149 |
| AnaemiaBlood and lymphatic system disorders | 0/112 | 1/149 | 0/149 |
| PneumoniaInfections and infestations | 0/112 | 0/149 | 1/149 |
| Femur fractureInjury, poisoning and procedural complications | 0/112 | 0/149 | 1/149 |
| Event | Brexpiprazole 1 mg | Brexpiprazole 2 mg | Placebo |
|---|---|---|---|
| SomnolenceNervous system disorders | 9/112 | 24/149 | 3/149 |
| InsomniaPsychiatric disorders | 16/112 | 18/149 | 22/149 |
| BradykinesiaNervous system disorders | 8/112 | 20/149 | 0/149 |
| ContusionInjury, poisoning and procedural complications | 9/112 | 9/149 | 19/149 |
| Salivary hypersecretionGastrointestinal disorders | 1/112 | 18/149 | 1/149 |
| Muscle rigidityMusculoskeletal and connective tissue disorders | 9/112 | 16/149 | 1/149 |
| AgitationPsychiatric disorders | 2/112 | 4/149 | 16/149 |
| Gait disturbanceGeneral disorders | 5/112 | 15/149 | 1/149 |
| FallInjury, poisoning and procedural complications | 9/112 | 14/149 | 9/149 |
| PyrexiaGeneral disorders | 9/112 | 11/149 | 8/149 |
| Age, Categorical(Participants) | Brexpiprazole 1 mg | Brexpiprazole 2 mg | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 4 | 4 | 15 |
| >=65 years | 105 | 145 | 145 | 395 |
| Age, Continuous(years) | Brexpiprazole 1 mg | Brexpiprazole 2 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 79.3 ± 7.4 | 80.2 ± 6.4 | 80.3 ± 6.7 | 80.0 ± 6.8 |
| Sex: Female, Male(Participants) | Brexpiprazole 1 mg | Brexpiprazole 2 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 71 | 105 | 87 | 263 |
| Male | 41 | 44 | 62 | 147 |
| Race (NIH/OMB)(Participants) | Brexpiprazole 1 mg | Brexpiprazole 2 mg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 112 | 149 | 149 | 410 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Brexpiprazole 1 mg | Brexpiprazole 2 mg | Placebo | Total |
|---|---|---|---|---|
| Japan | 112 | 149 | 149 | 410 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Otsuka Pharmaceutical Co., Ltd.