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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2020-11-20

Study results available
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Summary

To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type

Conditions

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

Interventions

DRUG

Brexpiprazole, OPC-34712

Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Eva Koheygi, MD · Otsuka Pharmaceutical Development and Commercialization, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States
  • Bulgaria
  • Canada
  • Finland
  • France
  • Russia
  • Slovenia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01922258 on ClinicalTrials.gov