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

NCT02192554 | Completed DMC

• 1 other identifier: 331-13-211
• Study Type: observational
• Target: 450
• Locations: 12 countries
• Sites: 84

Brief Summary

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

Conditions

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

Keywords

OPC-34712; brexpiprazole; Dementia; Alzheimer's Disease; Cognitive Disorders; Memory; Agitation

Outcome Measures

Primary Outcomes (2)

• Adverse Events (AEs)

  Baseline to Month 2/Early Termination

• Mini-Mental State Examination (MMSE) score

  Baseline to Month 2/Early Termination

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• H. Lundbeck A/S: collaborator

Study Sites (84)

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Tuscaloosa, Alabama, 35404, United States

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Costa Mesa, California, 92626, United States

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Lakewood, California, 90805, United States

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Orange, California, 92868, United States

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Redlands, California, 92373, United States

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Bradenton, Florida, 34205, United States

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Hialeah, Florida, 33012, United States

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Hialeah, Florida, 33018, United States

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Miami, Florida, 33122, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33137, United States

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Miami, Florida, 33175, United States

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Miami Springs, Florida, 33166, United States

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North Miami, Florida, 33161, United States

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Orange City, Florida, 32763, United States

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Sarasota, Florida, 34239, United States

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Atlanta, Georgia, 30331, United States

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Suwanee, Georgia, 30024, United States

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Quincy, Massachusetts, 02169, United States

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St Louis, Missouri, 63128, United States

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Toms River, New Jersey, 08755, United States

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Brooklyn, New York, 11214, United States

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New Hyde Park, New York, 11040, United States

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Charlotte, North Carolina, 28270, United States

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Hickory, North Carolina, 28601, United States

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Raleigh, North Carolina, 27609, United States

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Dallas, Texas, 75243, United States

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Waukesha, Wisconsin, 53188, United States

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Burgas, 8000, Bulgaria

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Kardzhali, 6600, Bulgaria

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Rousse, 7003, Bulgaria

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Sofia, 1113, Bulgaria

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Sofia, 1431, Bulgaria

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Varna, 9020, Bulgaria

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Veliko Tarnovo, 5000, Bulgaria

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Penticton, British Columbia, V2A 4M4, Canada

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Kentville, Nova Scotia, B4N 4K9, Canada

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Zagreb, 10000, Croatia

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Zagreb, 10090, Croatia

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Bourg N Bresse, 01012, France

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Douai, 59500, France

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Élancourt, 78990, France

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Toulouse, 31059, France

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Mittweida, Saxony, 9648, Germany

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Berlin, 12209, Germany

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Bochum, 44791, Germany

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Cologne, 50935, Germany

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Westerstede, 26655, Germany

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Saint Petersburg, 190000, Russia

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Saint Petersburg, 190005, Russia

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Saint Petersburg, 191040, Russia

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Saint Petersburg, 191119, Russia

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Saint Petersburg, 192019, Russia

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Saint Petersburg, 195176, Russia

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Saint Petersburg, 197341, Russia

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Saint Petersburg, 198510, Russia

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Samara, 443016, Russia

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Saratov, 410060, Russia

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Tonnelniy, 357034, Russia

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Yekaterinburg, 620030, Russia

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Belgrade, 11000, Serbia

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Kovin, 26220, Serbia

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Kragujevac, 34000, Serbia

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Niš, 18000, Serbia

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Novi Kneževac, 23330, Serbia

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Novi Sad, 21000, Serbia

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Ljubljana, 1000, Slovenia

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Maribor, 2000, Slovenia

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Šempeter pri Gorici, 5290, Slovenia

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Pamplona, 31014, Spain

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Salamanca, 37004, Spain

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Valencia, 46010, Spain

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Valencia, 46026, Spain

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Zamora, 49021, Spain

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Kharkiv, 61068, Ukraine

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Kherson, 73488, Ukraine

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Kiev, 04080, Ukraine

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Kiev, 04114, Ukraine

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Lviv, 79021, Ukraine

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Odesa, 35006, Ukraine

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Odesa, 67513, Ukraine

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Poltava, 36013, Ukraine

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Vinnytsia, 21005, Ukraine

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Torpoint, PL11 2TB, United Kingdom

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MeSH Terms

Conditions

Mental Disorders; Nervous System Diseases; Dementia; Alzheimer Disease; Cognitive Dysfunction; Psychomotor Agitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Cognition Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Study Officials

• Eva Kohegyi, MD, MS

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 17, 2014
• Study Start: June 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 30, 2018

Record last verified: 2018-04

Locations

US (28); RU (12); GB (1); SE (6); FR (4); SL (3); CR (2); DE (5); BU (7); CA (2); ES (5); UA (9)