Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

OPC-34712brexpiprazoleDementiaAlzheimer's DiseaseCognitive DisordersMemoryAgitation

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

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

H. Lundbeck A/S
Industrycollaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industrylead

Study Sites (84)

Tuscaloosa, Alabama, 35404, United States

Costa Mesa, California, 92626, United States

Lakewood, California, 90805, United States

Orange, California, 92868, United States

Redlands, California, 92373, United States

Bradenton, Florida, 34205, United States

Hialeah, Florida, 33012, United States

MeSH Terms

Conditions

Mental DisordersNervous System DiseasesDementiaAlzheimer DiseaseCognitive DysfunctionPsychomotor Agitation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNeurocognitive DisordersTauopathiesNeurodegenerative DiseasesCognition DisordersDyskinesiasNeurologic ManifestationsPsychomotor Disorders

Study Officials

Eva Kohegyi, MD, MS
Otsuka Pharmaceutical Development & Commercialization, Inc.
STUDY DIRECTOR

Enrollment

450 participants (actual enrollment reported by the registry).

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 2014

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (84)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (84)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations