Other Clinical Trial - Brexpiprazole for the Treatment of Patients With

Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Agitation Associated With Dementia of the Alzheimer's Type Clinical Trial

Official title:
A Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Clinical Trial Summary

To evaluate the superiority of brexpiprazole 1 mg or 2 mg over placebo after a 10-week treatment regimen for agitation associated with dementia of the Alzheimer's type in patients who require medication, and to investigate the safety of brexpiprazole and identify the optimum dose.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT03724942` - Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type	Phase 3
	Terminated	`NCT02168920` - Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type	Phase 3

See also

Status

Clinical Trial

Phase

Completed

NCT03724942 - Brexpiprazole for the Long-term Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Phase 3

Terminated

NCT02168920 - Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT03620981
Study type	Interventional
Source	Otsuka Pharmaceutical Co., Ltd.
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	August 20, 2018
Completion date	May 15, 2023

Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms