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Agitation Associated With Alzheimer's DiseaseNCT02192554

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

An observational study of Agitation Associated With Alzheimer's Disease and Alzheimer's Type, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 84 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Any age
How many people
450 participants
Where
84 sitesin 12 countries
Study dates
Jun 2014to May 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

84 sites in 12 countries.

84 sites in 12 countries

United States28 sites

  • Study site

    Atlanta, Georgia, 30331

  • Study site

    Bradenton, Florida, 34205

  • Study site

    Brooklyn, New York, 11214

  • Study site

    Charlotte, North Carolina, 28270

  • Study site

    Costa Mesa, California, 92626

  • Study site

    Dallas, Texas, 75243

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Hialeah, Florida, 33018

  • Study site

    Hickory, North Carolina, 28601

  • Study site

    Lakewood, California, 90805

  • Study site

    Miami, Florida, 33122

  • Study site

    Miami, Florida, 33126

  • Study site

    Miami, Florida, 33137

  • Study site

    Miami, Florida, 33175

  • Study site

    Miami Springs, Florida, 33166

  • Study site

    New Hyde Park, New York, 11040

  • Study site

    North Miami, Florida, 33161

  • Study site

    Orange, California, 92868

  • Study site

    Orange City, Florida, 32763

  • Study site

    Quincy, Massachusetts, 02169

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Redlands, California, 92373

  • Study site

    Sarasota, Florida, 34239

  • Study site

    St Louis, Missouri, 63128

  • Study site

    Suwanee, Georgia, 30024

  • Study site

    Toms River, New Jersey, 08755

  • Study site

    Tuscaloosa, Alabama, 35404

  • Study site

    Waukesha, Wisconsin, 53188

Other trials in United States

Russia12 sites

  • Study site

    Saint Petersburg, 190000

  • Study site

    Saint Petersburg, 190005

  • Study site

    Saint Petersburg, 191040

  • Study site

    Saint Petersburg, 191119

  • Study site

    Saint Petersburg, 192019

  • Study site

    Saint Petersburg, 195176

  • Study site

    Saint Petersburg, 197341

  • Study site

    Saint Petersburg, 198510

  • Study site

    Samara, 443016

  • Study site

    Saratov, 410060

  • Study site

    Tonnelniy, 357034

  • Study site

    Yekaterinburg, 620030

Other trials in Russia

Ukraine9 sites

  • Study site

    Kharkiv, 61068

  • Study site

    Kherson, 73488

  • Study site

    Kiev, 04080

  • Study site

    Kiev, 04114

  • Study site

    Lviv, 79021

  • Study site

    Odesa, 35006

  • Study site

    Odesa, 67513

  • Study site

    Poltava, 36013

  • Study site

    Vinnytsia, 21005

Other trials in Ukraine

Bulgaria7 sites

  • Study site

    Burgas, 8000

  • Study site

    Kardzhali, 6600

  • Study site

    Rousse, 7003

  • Study site

    Sofia, 1113

  • Study site

    Sofia, 1431

  • Study site

    Varna, 9020

  • Study site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Serbia6 sites

  • Study site

    Belgrade, 11000

  • Study site

    Kovin, 26220

  • Study site

    Kragujevac, 34000

  • Study site

    Niš, 18000

  • Study site

    Novi Kneževac, 23330

  • Study site

    Novi Sad, 21000

Other trials in Serbia

Germany5 sites

  • Study site

    Berlin, 12209

  • Study site

    Bochum, 44791

  • Study site

    Cologne, 50935

  • Study site

    Mittweida, Saxony, 9648

  • Study site

    Westerstede, 26655

Other trials in Germany

Spain5 sites

  • Study site

    Pamplona, 31014

  • Study site

    Salamanca, 37004

  • Study site

    Valencia, 46010

  • Study site

    Valencia, 46026

  • Study site

    Zamora, 49021

Other trials in Spain

France4 sites

  • Study site

    Bourg N Bresse, 01012

  • Study site

    Douai, 59500

  • Study site

    Élancourt, 78990

  • Study site

    Toulouse, 31059

Other trials in France

Slovenia3 sites

  • Study site

    Ljubljana, 1000

  • Study site

    Maribor, 2000

  • Study site

    Sempeter pri Gorici, 5290

Other trials in Slovenia

Canada2 sites

  • Study site

    Kentville, Nova Scotia, B4N 4K9

  • Study site

    Penticton, British Columbia, V2A 4M4

Other trials in Canada

Croatia2 sites

  • Study site

    Zagreb, 10000

  • Study site

    Zagreb, 10090

Other trials in Croatia

United Kingdom1 site

  • Study site

    Torpoint, PL11 2TB

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Keywords
OPC-34712, brexpiprazole, Dementia, Alzheimer's Disease, Cognitive Disorders, Memory, Agitation
Medical subject headings
Mental Disorders, Nervous System Diseases, Dementia, Alzheimer Disease, Cognitive Dysfunction, Psychomotor Agitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events (AEs)

    Measured: Baseline to Month 2/Early Termination

  2. Mini-Mental State Examination (MMSE) score

    Measured: Baseline to Month 2/Early Termination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02192554
Sponsor's protocol ID
331-13-211
Status last verified
Apr 2018
First submitted
15 Jul 2014
Last updated
30 Apr 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Agitation Associated With Alzheimer's Disease and Alzheimer's Type, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 84 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Russia, Ukraine, Bulgaria, Serbia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: Baseline to Month 2/Early Termination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02192554.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.

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