Phase 3
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
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT03594123 ↗Enrolled (actual)
259
Serious AEs
2.3%
Results posted
Nov 2023
Primary outcome: Primary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity — 20.9; 13.5; 9.2; 19.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brexpiprazole (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Sep 2022
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 | — |
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).
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). 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.