A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).
研究概览
简要总结
The primary purpose of this study is to determine whether ELND005 is effective in treating symptoms of agitation and aggression in patients with 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
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Probable AD according to the National Institute on Aging- Alzheimer's Association (NIA-AA) guidelines (McKhann et al 2011).
- •MMSE score of 5 to 24 (inclusive) at the Screening Visit.
- •Has clinically significant agitation/aggression defined as Neuropsychiatric Inventory (NPI)-agitation/aggression subscore of ≥
- •No response or suboptimal response to standard nonpharmacological interventions.
排除标准
- •The agitation/aggression is attributable to concomitant medications, environmental conditions, or active medical or psychiatric condition.
- •Current diagnosis of major depressive disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM IV TR).
- •Has persistent and distressing psychotic symptoms (delusion and/or hallucinations) that require psychiatric hospitalization.
研究组 & 干预措施
ELND005
ELND005 film coated tablets, BID for 12 weeks
干预措施: ELND005 (Drug)
Placebo
Matched placebo BID for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in NPI-C Combined Agitation and Aggression Subscores (NPI-C A+A).
时间窗: Week 12
The NPI-C (de Medeiros et al 2010) is a validated and reliable behavioral measure that assesses psychopathology in dementia subjects. It evaluates 14 neuropsychiatric disturbances common in dementia.Higher scores on the NPI-C are associated with a greater clinical severity of symptoms. The NPI-C Agitation and Aggression score ranges from 0-63. The analysis of the NPI-C A+A score was performed on the mITT population.
次要结局
- Change From Baseline in Modified-ADCS-CGIC Agitation Scores(Week 12)
- Change From Baseline in NPI Total Scores(Week 12)
- Change From Baseline in MMSE Scores(Week 12)
- Change From Baseline in ADCS-ADL Scores(Week 12)