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

Phase 3CompletedNCT03620981

Otsuka Pharmaceutical Co., Ltd.410 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

410

Conditions

Agitation Associated With Dementia of the Alzheimer's Type

Interventions

BrexpiprazoleDRUG

Drug: 1 tablet /day Once daily for 10 weeks

PlaceboDRUG

Placebo: 1 tablet /day Once daily for 10 weeks

Eligibility

Sex: ALLMin age: 55 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Jisenkai Nanko Psychiatric Institute

Shirakawa, Japan

Outcomes

Primary Outcomes

Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.

The CMAI assessed the frequency of agitated behaviors in elderly persons, such as hitting, cursing, and restlessness. It consisted of 29 items all rated on a 1 to 7 scale with 1 being the "best" rating and 7 being the "worst" rating. The minimum possible CMAI total score was 29, and the maximum possible CMAI total score was 203. A decrease in score indicated improvement in symptoms.

Time frame: Baseline and 10 weeks first dose, on average 10 weeks

Secondary Outcomes

Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.

The CGI-S was used to rate the severity of agitation. Scores were: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. A decrease in score indicated improvement in symptoms.

Time frame: Baseline and 10 weeks first dose, on average 10 weeks

Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.

The CGI-I Scale was clinician-rated scale which assessed the total improvement of the patient's condition compared to that at baseline. Scores range from 0 to 7: 0 = Not assessed, 1= Very much improved, 2 = Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Higher scores indicate worse condition.

Time frame: Baseline and 10 weeks first dose, on average 10 weeks

Data from ClinicalTrials.gov

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