Safety Follow-up Study for Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Previously Participated in a Double-blind Trial of Brexpiprazole or Placebo

April 27, 2018 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A 2-Month, Observational, Rollover Trial to Evaluate the Safety of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Were Previously Treated With Brexpiprazole (OPC 34712) or Placebo in a Phase 3, Double-blind Trial

To follow-up on the safety of subjects who were previously treated in a double-blind trial of brexpiprazole.

Study Overview

Status

Completed

Conditions

Detailed Description

Behavioral symptoms, such as agitation, are core features in subjects with Alzheimer's disease and related dementias, and develop in the majority of dementia subjects. The presence of agitation in subjects with Alzheimer's disease places a significant burden not only on subjects and their caregivers but also on the healthcare system.

This is a trial designed to assess the ongoing safety of subjects with agitation associated with dementia of the Alzheimer's type after completing a 12-week double-blind trial of brexpiprazole or placebo; drug and placebo are discontinued prior to subjects enrolling in the safety follow-up trial. The trial consists of a continuous 2 month observation period. The trial population will include male and female subjects with a diagnosis of probable Alzheimer's disease.

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
      • Kardzhali, Bulgaria, 6600
      • Ruse, Bulgaria, 7003
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1113
      • Varna, Bulgaria, 9020
      • Veliko Tŭrnovo, Bulgaria, 5000
  • Canada
    • British Columbia
      • Penticton, British Columbia, Canada, V2A 4M4
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 4K9
  • Croatia
      • Zagreb, Croatia, 10000
      • Zagreb, Croatia, 10090
  • France
      • Bourg N Bresse, France, 01012
      • Douai, France, 59500
      • Elancourt, France, 78990
      • Toulouse, France, 31059
  • Germany
      • Berlin, Germany, 12209
      • Bochum, Germany, 44791
      • Koln, Germany, 50935
      • Westerstede, Germany, 26655
    • Saxony
      • Mittweida, Saxony, Germany, 9648
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620030
      • Samara, Russian Federation, 443016
      • Saratov, Russian Federation, 410060
      • St. Petersburg, Russian Federation, 192019
      • St. Petersburg, Russian Federation, 197341
      • St. Petersburg, Russian Federation, 190000
      • St. Petersburg, Russian Federation, 190005
      • St. Petersburg, Russian Federation, 191119
      • St. Petersburg, Russian Federation, 198510
      • St. Petersburg, Russian Federation, 191040
      • St. Petersburg, Russian Federation, 195176
      • Tonnelniy, Russian Federation, 357034
  • Serbia
      • Belgrade, Serbia, 11000
      • Kovin, Serbia, 26220
      • Kragujevac, Serbia, 34000
      • Niš, Serbia, 18000
      • Novi Knezevac, Serbia, 23330
      • Novi Sad, Serbia, 21000
  • Slovenia
      • Ljubljana, Slovenia, 1000
      • Maribor, Slovenia, 2000
      • Sempeter pri Gorici, Slovenia, 5290
  • Spain
      • Pamplona, Spain, 31014
      • Salamanca, Spain, 37004
      • Valencia, Spain, 46026
      • Valencia, Spain, 46010
      • Zamora, Spain, 49021
  • Ukraine
      • Kharkiv, Ukraine, 61068
      • Kherson, Ukraine, 73488
      • Kiev, Ukraine, 04080
      • Kiev, Ukraine, 04114
      • Lviv, Ukraine, 79021
      • Odessa, Ukraine, 67513
      • Odessa, Ukraine, 35006
      • Poltava, Ukraine, 36013
      • Vinnytsia, Ukraine, 21005
  • United Kingdom
      • Torpoint, United Kingdom, PL11 2TB
  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35404
    • California
      • Costa Mesa, California, United States, 92626
      • Lakewood, California, United States, 90805
      • Orange, California, United States, 92868
      • Redlands, California, United States, 92373
    • Florida
      • Bradenton, Florida, United States, 34205
      • Hialeah, Florida, United States, 33012
      • Hialeah, Florida, United States, 33018
      • Miami, Florida, United States, 33137
      • Miami, Florida, United States, 33126
      • Miami, Florida, United States, 33175
      • Miami, Florida, United States, 33122
      • Miami Springs, Florida, United States, 33166
      • North Miami, Florida, United States, 33161
      • Orange City, Florida, United States, 32763
      • Sarasota, Florida, United States, 34239
    • Georgia
      • Atlanta, Georgia, United States, 30331
      • Suwanee, Georgia, United States, 30024
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
    • Missouri
      • Saint Louis, Missouri, United States, 63128
    • New Jersey
      • Toms River, New Jersey, United States, 08755
    • New York
      • Brooklyn, New York, United States, 11214
      • New Hyde Park, New York, United States, 11040
    • North Carolina
      • Charlotte, North Carolina, United States, 28270
      • Hickory, North Carolina, United States, 28601
      • Raleigh, North Carolina, United States, 27609
    • Texas
      • Dallas, Texas, United States, 75243
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects must have completed a previous double-blind trial of brexpiprazole or placebo; neither drug or placebo will be administered in the trial

Description

Inclusion Criteria:

  • The investigator must assess the capacity of the subject to provide informed consent prior to enrollment and throughout the trial.
  • Male and female subjects who completed both the 12-week double-blind treatment period and the 30-day safety follow-up visit of the previous brexpiprazole trial.
  • Subject has an identified caregiver who is usually assigned to care for the subject on a regular basis, has sufficient contact to describe the subject's symptoms, and has direct observation of the subject's behavior.
  • Subject is able to comply with the protocol requirements.

Exclusion Criterion:

  • Subjects who, in the opinion of the investigator, medical monitor, or sponsor should not participate in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse Events (AEs)
Time Frame: Baseline to Month 2/Early Termination
Baseline to Month 2/Early Termination
Mini-Mental State Examination (MMSE) score
Time Frame: Baseline to Month 2/Early Termination
Baseline to Month 2/Early Termination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Collaborators

H. Lundbeck A/S

Investigators

  • Study Director: Eva Kohegyi, MD, MS, Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 17, 2014

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 331-13-211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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