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

Otsuka Pharmaceutical Co., Ltd.164 enrolled

Overview

To evaluate the safety of brexpiprazole 1 mg or 2 mg after a 14 week treatment regimen for agitation associated with dementia of the Alzheimer's type patients who completed in a double-blind trial, and to investigate the efficacy of brexpiprazole.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Agitation Associated With Dementia of the Alzheimer's Type

Interventions

BrexpiprazoleDRUG

Brexpiprazole 1mg or 2mg will be orally once daily for 14 weeks

Eligibility

Sex: ALLMin age: 55 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who completed the double-blind treatment period for 10 weeks and all observation, examination and evaluation at Week 10 of the double-blind trial. * Patients whose caregiver can properly collect the necessary information. Exclusion Criteria: * Patients who had a serious adverse event which the principal investigator or sub-investigator assessed as related to the investigator product during the double-blind trial. * Patients who had delirium during the double-blind trial.

Locations (1)

Jisenkai Nanko Psychiatric Institute

Shirakawa, Japan

Outcomes

Primary Outcomes

The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs)

This trial enrolled subjects rolled over from Trial 331-102-00088, and the safety of brexpiprazole when administered for a maximum of 24 weeks (including the treatment period of Trial 331-102-00088) was evaluated.

Time frame: From baseline to week 14

Secondary Outcomes

Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 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 14 weeks after dosing

Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 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 14 weeks after dosing.

Clinical Global Impression of Improvement (CGI-I) Score at 14 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: 14 weeks after dosing.

Data from ClinicalTrials.gov

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