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Completed

NCT Number: NCT03620981

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

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.

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Key information

Conditions

Agitation Associated With Dementia of the Alzheimer's Type

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / 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 satisfy both of the following diagnostic criteria:
  • Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-5.
  • 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

Treatment and study plan

Brexpiprazole

Drug

Drug: 1 tablet /day Once daily for 10 weeks

Placebo

Drug

Placebo: 1 tablet /day Once daily for 10 weeks

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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 Phase 2/3 Multicenter, Placebo-controlled, Randomized, Double-blind, Parallel-group Comparison Trial to Evaluate the Efficacy and Safety of Brexpiprazole (OPC-34712) in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2018
Registry last updated
Nov 14, 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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