Clinical trial NCT02192554: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2014-07-17
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Baseline to Month 2/Early Termination
measure: Mini-Mental State Examination (MMSE) score
timeFrame: Baseline to Month 2/Early Termination
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
state: Alabama
city: Costa Mesa
country: United States
state: California
city: Lakewood
country: United States
state: California
city: Orange
country: United States
state: California
city: Redlands
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Miami Springs
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: Orange City
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Suwanee
country: United States
state: Georgia
city: Quincy
country: United States
state: Massachusetts
city: Saint Louis
country: United States
state: Missouri
city: Toms River
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Dallas
country: United States
state: Texas
city: Waukesha
country: United States
state: Wisconsin
city: Burgas
country: Bulgaria
city: Kardzhali
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Varna
country: Bulgaria
city: Veliko Tŭrnovo
country: Bulgaria
city: Penticton
country: Canada
state: British Columbia
city: Kentville
country: Canada
state: Nova Scotia
city: Zagreb
country: Croatia
city: Zagreb
country: Croatia
city: Bourg N Bresse
country: France
city: Douai
country: France
city: Elancourt
country: France
city: Toulouse
country: France
city: Mittweida
country: Germany
state: Saxony
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Koln
country: Germany
city: Westerstede
country: Germany
city: Ekaterinburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Saratov
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Tonnelniy
country: Russian Federation
city: Belgrade
country: Serbia
city: Kovin
country: Serbia
city: Kragujevac
country: Serbia
city: Niš
country: Serbia
city: Novi Knezevac
country: Serbia
city: Novi Sad
country: Serbia
city: Ljubljana
country: Slovenia
city: Maribor
country: Slovenia
city: Sempeter pri Gorici
country: Slovenia
city: Pamplona
country: Spain
city: Salamanca
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zamora
country: Spain
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Odessa
country: Ukraine
city: Poltava
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Torpoint
country: United Kingdom
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Eva Kohegyi, MD, MS
role: STUDY_DIRECTOR
References: