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

Otsuka

Status and phase: Completed; Phase 3; Phase 2

Conditions: Agitation Associated With Dementia of the Alzheimer's Type

Treatments: Drug: Placebo; Drug: Brexpiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03620981

331-102-00088

Details and patient eligibility

About

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.

Enrollment: 410 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who satisfy both of the following diagnostic criteria:

  1. Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-5.
  2. Diagnosis of "Probable Alzheimer's Disease" according to NINCDS-ADRDA.

• Hospitalized patients or care facility patients or care at home patients

• Patients with an MMSE score of 1 to 22

• Patients who have the agitation defined according to the "Consensus provisional definition of agitation in cognitive disorders" from the International Psychogeriatric Association (IPA)

Exclusion criteria

• Patients who have dementia other than dementia of the Alzheimer's type

• Patients diagnosed with delirium between 30 days before the screening examination and baseline evaluation according to DSM-5.

• Patients diagnosed with any of the following disorders according to DSM-5:

  • Schizophrenia spectrum and other psychotic disorders
  • Bipolar and related disorders
  • Major depressive disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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410 participants in 3 patient groups, including a placebo group

Brexpiprazole, 1mg/day

Experimental group

Description:

Drug: 1mg/day Once daily for 10 weeks

Treatment:

Drug: Brexpiprazole

Brexpiprazole, 2mg/day

Experimental group

Description:

Drug: 2mg/day Once daily for 10 weeks

Treatment:

Drug: Brexpiprazole

Placebo

Placebo Comparator group

Description:

Drug: Placebo (0mg/day) Once daily for 10 weeks

Treatment:

Drug: Placebo