# A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation

> **NCT01862640** · PHASE3 · COMPLETED · sponsor: **Otsuka Pharmaceutical Development & Commercialization, Inc.** · enrollment: 433 (actual)

## Conditions studied

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

## Interventions

- **DRUG:** Brexpiprazole, OPC-34712
- **DRUG:** Placebo Oral Tablet

## Key facts

- **NCT ID:** NCT01862640
- **Lead sponsor:** Otsuka Pharmaceutical Development & Commercialization, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2013-07-11
- **Primary completion:** 2017-03-15
- **Final completion:** 2017-03-15
- **Target enrollment:** 433 (ACTUAL)
- **Last updated:** 2020-12-31

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01862640

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01862640, "A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT01862640. Licensed CC0.

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