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BREXPIPRAZOLE study (flexible dosing)

Clinical Trials Watch

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Study Information

Name of the study

Safety and tolerability study of flexible dosing of Brexpiprazole in the treatment of subjects with agitation associated with dementia of the Alzheimer's type

Study sponsor



Alzheimer’s disease

Information about the drug that will be tested in the study

Name of drug

Brexpiprazole (also known as “OPC-34712”)


A tablet, oral

Is the drug already on the market for another medical condition?

The drug has been used for people with mental health problems

Will all participants receive the same drug?

Participants will be selected at random to either receive:

  • A flexible dose of Brexpiprazole (this means that the study doctor will decide which is the best dose of the drug for the person, ranging from 0.5 to 2 mg/day).
  • The placebo (a dummy treatment).

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the safety and efficacy of brexpiprazole (when taken in a “flexible” dose) as a treatment for agitation for people with Alzheimer’s disease.

How long will the treatment last?

Participants will be asked to take the drug for 12 weeks.

Once the 12-weeks treatment is finished, participants will be followed up for 30 days to ensure safety.

What will your involvement entail?

During the study, participants (and / or their caregivers) will be asked to complete different tests that will assess agitation, anxiety, aggressive behaviour, irritability, delusions and hallucinations, quality of life, and use of resources.

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in this study?

To take part in the study, participants must:

  • Be 55-90 years old
  • Have a diagnosis of Alzheimer’s disease
  • Have a brain scan (MRI or CT) with findings consistent with the diagnosis of Alzheimer’s disease
  • At the time of the screening visit the score of the memory test (a test called MMSE) should be between 5 and 22
  • Live in an institution (e.g. nursing home, assisted living facility, dementia unit, residential facility, etc.), or if living at home, the person should not be living alone
  • The person must have been in their current location (i.e. institution or at home) for at least 14 days prior to the screening visit and plan to remain at the same location for the duration of the trial
  • Have symptoms of agitation for at least 2 weeks prior to the screening visit
  • Need treatment with medication for agitation after having ruled out reversible factors that could explain the agitation and tried other non-pharmacological approaches

Who cannot participate in the study?

People cannot take part if they have / are :

  • Any other type of dementia that is not Alzheimer’s disease.
  • Uncontrolled hypertension.
  • Uncontrolled insulin dependent diabetes.
  • Epilepsy or seizures.
  • Infection that needs to be treated with antibiotics or that requires hospitalization within 2 weeks of the screening visit.
  • History of strokes or mini-strokes, traumatic brain injury.
  • Deep vein thrombosis within 5 years prior to screening visit.
  • Depression, anxiety disorder, bipolar disorder, autism, anorexia, bulimia, schizophrenia, intellectual disability.
  • Bedridden
  • Unable to swallow tablets

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Where and when will the study be conducted?

European countries involved in the trial

  • France
  • Russian Federation
  • Ukraine
  • Slovenia

Estimated start date of recruitment

September 2013

Completion date

June 2017

Information for your doctor

EudraCT Number:

2013-000503-17 identifier


Study contact information

Link to full text

The information contained in this document is based on information available on public registries (e.g. website)

The pharmaceutical company running this trial (OTSUKA) has reviewed this document.

This document has been reviewed by a member of the European Working Group of People with Dementia.



Last Updated: Wednesday 13 July 2016