Phase 3
Completed 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
Source: ClinicalTrials.gov NCT03724942 ↗
Enrolled (actual)
164
Serious AEs
6.7%
Results posted
Sep 2024
Primary outcomePrimary: The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs) — 90.2; 90.3 Percentage of percipitante
◆ Published Evidence
Emerging
3citations · ~3 / year
Long-term safety and tolerability of brexpiprazole for Japanese patients with agitation in Alzheimer's disease dementia: A multicenter, open-label study.
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.
Linked Publications
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Long-term safety and tolerability of brexpiprazole for Japanese patients with agitation in Alzheimer's disease dementia: A multicenter, open-label study.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.