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
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02192554 |
|
Recruitment Status :
Completed
First Posted : July 17, 2014
Last Update Posted : April 30, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Agitation Associated With Alzheimer's Disease Alzheimer's Type Mental Disorder Nervous System Diseases |
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 |
- Adverse Events (AEs) [ Time Frame: Baseline to Month 2/Early Termination ]
- Mini-Mental State Examination (MMSE) score [ Time Frame: Baseline to Month 2/Early Termination ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
| Study Director: | Eva Kohegyi, MD, MS | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| ClinicalTrials.gov Identifier: | NCT02192554 |
| Other Study ID Numbers: |
331-13-211 |
| First Posted: | July 17, 2014 Key Record Dates |
| Last Update Posted: | April 30, 2018 |
| Last Verified: | April 2018 |
|
OPC-34712 brexpiprazole Dementia Alzheimer's Disease |
Cognitive Disorders Memory Agitation |
|
Alzheimer Disease Dementia Psychomotor Agitation Nervous System Diseases Mental Disorders Brain Diseases Central Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Dyskinesias Neurologic Manifestations Psychomotor Disorders Neurobehavioral Manifestations |