Phase 3
Completed N=259
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Source: ClinicalTrials.gov NCT03594123 ↗Enrolled (actual)
259
Serious AEs
2.3%
Results posted
Nov 2023
Primary outcomePrimary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity — 20.9; 13.5; 9.2; 19.8 percentage of participants
◆ Published Evidence
Emerging
13citations · ~7 / year
Brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer's disease: A 12-week, active-treatment, extension trial.
Summary
Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type (AAD).
Linked Publications (4)
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Brexpiprazole for the treatment of agitation associated with dementia due to Alzheimer's disease: A 12-week, active-treatment, extension trial.
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Safety and Tolerability of Brexpiprazole in Participants with Agitation Associated with Dementia due to Alzheimer's Disease: Pooled Analysis of Three Randomized Trials and an Extension Trial.
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Short-Term and Long-Term Safety Analyses of Brexpiprazole for Agitation Associated with Dementia due to Alzheimer's Disease: Timing and Duration of Adverse Events.
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Brexpiprazole side-effect profile in people with agitation in Alzheimer's dementia: a plain language summary.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity |
20.9; 13.5; 9.2; 19.8; 3.1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have participated in the 331-14-213 study.
- Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.
Exclusion Criteria
- Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.
Data sourced from ClinicalTrials.gov (NCT03594123) 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.