Phase 3
N=164
Brexpiprazole for the Long-term 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: NCT03724942 ↗Enrolled (actual)
164
Serious AEs
6.7%
Results posted
Sep 2024
Primary outcome: Primary: The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) — 90.2; 90.3 Percentage of percipitante
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexpiprazole (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) |
90.2; 90.3 | — |
| SECONDARY Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing |
-2.5; -6.4 | — |
| SECONDARY Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing. |
-0.2; -0.4 | — |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing |
3.1; 2.7 | — |
Summary
To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.
Eligibility Criteria
Inclusion Criteria
- Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial.
- Patients whose caregiver can properly collect the necessary information.
Exclusion Criteria
- Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial.
- Patients who had delirium during the double-blind trial.
Data sourced from ClinicalTrials.gov (NCT03724942). 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.