A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 in the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 177
- 主要终点
- Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including Alzheimer's disease.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of probable Alzheimer's disease
- •Clinically significant symptoms of agitation secondary to probable Alzheimer's disease
- •Able to attend outpatient clinic visits with primary caregiver
排除标准
- •Unable to comply with study procedures
- •Considered medically inappropriate for study participation
研究组 & 干预措施
ITI-007
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.
干预措施: ITI-007 (Drug)
Placebo
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
时间窗: 4 weeks (28 Days)
The Cohen-Mansfield Agitation Inventory-Community Version is a 37-item scale for identifying and quantifying agitated behaviors in elderly persons in a community setting. Each item is rated from 1='Never' to 7='Several Times Per Hour'. Each category contains a pre-specified subset of the CMAI-C items. The score of each category is the sum of the CMAI-C items included in that category: Aggressive Behavior-Sum of 9 CMAI-C items, ranges from 9 to 63; Non-Aggressive Agitated Behavior-Sum of 6 CMAI-C items, ranges from 6 to 42; Verbally Agitated Behavior-Sum of 4 CMAI-C items, ranges from 4 to 28.
次要结局
- Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)(4 weeks (28 Days))