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Completed

NCT Number: NCT03724942

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

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.

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Key information

Conditions

Agitation Associated With Dementia of the Alzheimer's Type

Age range

55 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jisenkai Nanko Psychiatric Institute

Shirakawa, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brexpiprazole

Drug

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

Other names: OPC-34712

Primary outcomes

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

    Time frame: 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 outcomes

  1. Mean Change From Baseline in Cohen-Mansfield Agitation Inventory (CMAI) Score at 14 Weeks After Dosing

    Time frame: 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.

  2. Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 14 Weeks After Dosing.

    Time frame: 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.

  3. Clinical Global Impression of Improvement (CGI-I) Score at 14 Weeks After Dosing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Safety of Extended Treatment With Brexpiprazole (OPC-34712) to Patients With Agitation Associated With Dementia of the Alzheimer's Type

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Oct 30, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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