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
CompletedPhase 3Results postedLast updated 14 November 2023
What this trial tests
Phase 3 trial testing Brexpiprazole in Alzheimer's Disease in 259 participants. Completed in 19 September 2022.
Adults 55 to 91, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by SeverityPrimary· From first dose through 30 days after last dose of study drug (Up to approximately Week 16)
An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with an onset date on or after the first dose of brexpiprazole. They are all adverse events that started after start of brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study therapy.
Adverse events were graded on a 3-poi
Mild
Group
Value
95% CI
Prior Brexpiprazole
20.9
Prior Placebo
13.5
Moderate
Group
Value
95% CI
Prior Brexpiprazole
9.2
Prior Placebo
19.8
Severe
Group
Value
95% CI
Prior Brexpiprazole
3.1
Prior Placebo
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first dose through 30 days after last dose of study drug (Up to approximately Week 16).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05962216 — Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders
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NCT05017311 — Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)
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NCT05504486 — Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
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NCT05169268 — Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia
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NCT04830215 — Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder
· Phase 4
· completed
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NCT07214727 — A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease
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NCT07105709 — Open-label Extension Study in Participants With Early Alzheimer's Disease
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Otsuka Pharmaceutical Development & Commercialization, Inc.
Last refreshed: 14 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03594123.