Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Sponsor
Otsuka Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03724942
Collaborator
(none)
164
1
1
37.9
4.3

Study Details

Study Description

Brief Summary

To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
164 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Safety of Extended Treatment With Brexpiprazole (OPC-34712) to Patients With Agitation Associated With Dementia of the Alzheimer's Type
Actual Study Start Date :
Nov 9, 2018
Actual Primary Completion Date :
Dec 2, 2021
Actual Study Completion Date :
Jan 5, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brexpiprazole

Drug: Brexpiprazole
Brexpiprazole 1mg or 2mg will be orally once daily for 14 weeks
Other Names:
  • OPC-34712
  • Outcome Measures

    Primary Outcome Measures

    1. The frequency of Adverse events [From baseline to week 14]

    Secondary Outcome Measures

    1. Mean change from baseline in Cohen-Mansfield Agitation Inventory (CMAI) score at 14 weeks after dosing [Baseline and 14 weeks after dosing]

    2. Mean change from baseline in Clinical Global Impression of Severity (CGI-S) score at 14 weeks after dosing [Baseline and 14 weeks after dosing]

    3. Mean change from baseline in Clinical Global Impression of Improvement (CGI-I) score at 14 weeks after dosing [Baseline and 14 weeks after dosing]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 89 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial.

    • Patients whose caregiver can properly collect the necessary information.

    Exclusion Criteria:
    • Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial.

    • Patients who had delirium during the double-blind trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jisenkai Nanko Psychiatric Institute Shirakawa Japan

    Sponsors and Collaborators

    • Otsuka Pharmaceutical Co., Ltd.

    Investigators

    • Study Director: Osamu Sato, Otsuka Pharmaceutical Co., Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Otsuka Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03724942
    Other Study ID Numbers:
    • 331-102-00184
    • JapicCTI-184179
    First Posted:
    Oct 30, 2018
    Last Update Posted:
    Jan 13, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 13, 2022