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

Phase 3

Completed

• Conditions: Agitation Associated With Dementia of the Alzheimer's Type
• Interventions: Drug: Brexpiprazole

• Registration Number: NCT03724942
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-28
• Study First Submitted QC: 2018-10-28
• Study First Posted: 2018-10-30
• Study Start: 2018-11-09
• Primary Completion: 2021-12-02
• Status Verified: 2022-01
• Study Completion: 2022-01-05
• Last Update Submitted: 2022-01-12
• Last Update Posted: 2022-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brexpiprazole	Brexpiprazole	-

Primary Outcome Measures

Name	Time	Method
The Frequency of Subjects With Treatment-Emergent Adverse Events (TEAEs)	From baseline to week 14	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.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing	Baseline and 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.
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing.	Baseline and 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.
Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing	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.

Trial Locations

Locations (1)

Jisenkai Nanko Psychiatric Institute; 🇯🇵 Shirakawa, Japan