# Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

> **NCT01922258** · PHASE3 · COMPLETED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 270 (actual)

## Conditions studied

- Agitation Associated With
- Alzheimer's Disease
- Alzheimer's Type
- Mental Disorder
- Nervous System Diseases

## Interventions

- **DRUG:** Brexpiprazole, OPC-34712

## Key facts

- **NCT ID:** NCT01922258
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-09
- **Primary completion:** 2017-03
- **Final completion:** 2017-03
- **Target enrollment:** 270 (ACTUAL)
- **Last updated:** 2020-11-20

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01922258

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01922258, "Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT01922258. Licensed CC0.

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