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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who satisfy both of the following diagnostic criteria:
- •Diagnosis of "Dementia due to Alzheimer's Disease" according to DSM-
- •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)
排除标准
- •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-
- •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
研究组 & 干预措施
Brexpiprazole, 1mg/day
Drug: 1mg/day Once daily for 10 weeks
干预措施: Brexpiprazole (Drug)
Brexpiprazole, 2mg/day
Drug: 2mg/day Once daily for 10 weeks
干预措施: Brexpiprazole (Drug)
Placebo
Drug: Placebo (0mg/day) Once daily for 10 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Cohen-Manfield Agitation Inventory(CMAI) Score at 10 Weeks After Dosing.
时间窗: 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.
次要结局
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at 10 Weeks After Dosing.(Baseline and 10 weeks first dose, on average 10 weeks)
- Clinical Global Impression of Improvement (CGI-I) Score at 10 Weeks After Dosing.(Baseline and 10 weeks first dose, on average 10 weeks)