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Trial record 3 of 3 for:    Brexpiprazole | Alzheimer Disease

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

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ClinicalTrials.gov Identifier: NCT02192554
Recruitment Status : Completed
First Posted : July 17, 2014
Last Update Posted : July 26, 2017
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease
Agitation Associated With Alzheimer's Disease Alzheimer's Type Mental Disorder Nervous System Diseases

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
Actual Enrollment : 450 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : June 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017





Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Baseline to Month 2/Early Termination ]
  2. Mini-Mental State Examination (MMSE) score [ Time Frame: Baseline to Month 2/Early Termination ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02192554


  Show 84 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S
Investigators
Study Director: Eva Kohegyi, MD, MS Otsuka Pharmaceutical Development & Commercialization, Inc.

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02192554     History of Changes
Other Study ID Numbers: 331-13-211
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
OPC-34712
brexpiprazole
Dementia
Alzheimer's Disease
Cognitive Disorders
Memory
Agitation

Additional relevant MeSH terms:
Alzheimer Disease
Mental Disorders
Psychotic Disorders
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Psychomotor Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Brexpiprazole
Dementia
Psychomotor Agitation
Tauopathies
Dyskinesias
Neurologic Manifestations
Neurobehavioral Manifestations
Signs and Symptoms
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents