Phase 3
N=410
Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Agitation Associated With Dementia of the Alzheimer's Type
Bottom Line
View on ClinicalTrials.gov: NCT03620981 ↗Enrolled (actual)
410
Serious AEs
5.6%
Results posted
Nov 2024
Primary outcome: Primary: Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing. — -11.7; -15.2; -8.0 units on a scale — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexpiprazole (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing. |
-11.7; -15.2; -8.0 | < 0.0001 sig |
| SECONDARY Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing. |
-1.0; -1.4; -0.6 | < 0.0001 sig |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing. |
3.1; 2.6; 3.5 | < 0.0001 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients who satisfy both of the following diagnostic criteria:
- Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-5.
- Diagnosis of "Probable Alzheimer's Disease" according to NINCDS-ADRDA.
- 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:
- Schizophrenia spectrum and other psychotic disorders
- Bipolar and related disorders
- Major depressive disorder
Data sourced from ClinicalTrials.gov (NCT03620981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.