# A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type

> **NCT03548584** · PHASE3 · COMPLETED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 345 (actual)

## Conditions studied

- Agitation Associated With Alzheimer's Dementia
- Alzheimer Dementia

## Interventions

- **DRUG:** Brexpiprazole
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT03548584
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-05-16
- **Primary completion:** 2022-05-23
- **Final completion:** 2022-06-01
- **Target enrollment:** 345 (ACTUAL)
- **Last updated:** 2023-09-18

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03548584

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03548584, "A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type". Retrieved via AI Analytics 2026-07-25 from https://api.ai-analytics.org/clinical/NCT03548584. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*