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

Study Identifier:
331-201-00182
ClinicalTrials.gov Identifier:
NCT03594123
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Results Availables

Study Protocol
Available Language: English
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Statistical Analysis Plan
Available Language: English
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Study Details

Medical Condition
  • Dementia/Alzheimer
Study Drug
  • Drug: Brexpiprazole
Date
Oct 2018 - Sep 2022
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 55 - 91 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Participants must have participated in the 331-14-213 study.
  • Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.
Exclusion Criteria
  • Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.

Protocol Summary

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).

Study Locations

Location
Status
Location
For additional information regarding sites, contact 844-687-8522
Miami, Florida, United States, 33155
Status
N/A
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Participants must have participated in the 331-14-213 study.
  • Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.
Exclusion criteria
  • Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.

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