EUCTR2012-004299-20-GB进行中（未招募）不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Has a diagnosis of Probable AD according to the National Institute on Aging-Alzheimer’s Association (NIA-AA) guidelines (McKhann et al 2011).
- •-Has an 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 =4 at both the Screening and Baseline Visits with a severity score of =2 and frequency score of =2.
- •-Has had either no response or suboptimal response to standard nonpharmacological interventions.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •-The agitation/aggression is attributable to concomitant medications, environmental conditions, or active medical or psychiatric condition.
- •-Has a 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.
- •-Treated with injectable depot preparations of an antipsychotic within 3 months of the Screening Visit.
- •-Has brain abnormalities from brain imaging performed at the Screening Visit, or from an MRI or CT scan taken within 1 year prior to the Screening Visit, that can be attributed to diseases or processes other than AD.
研究者
相似试验
进行中（未招募）
1 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group,Multicenter Study of the Efficacy and Safety of Dapoxetine in Men With PrematureEjaculation and Concomitant Erectile Dysfunction Treated With aPhosphodiesterase-5 Inhibitor - COUPLEPremature ejaculationEUCTR2009-013616-12-FRJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
进行中（未招募）
1 期
A study to test the safety and effectiveness of Bay 41-6551 as additional therapy to standard of care antimicrobial treatment in patients who have Gram-Negative Pneumonia and are intubated and mechanially ventilated.Gram-negative pneumoniaMedDRA version: 20.1 Level: LLT Classification code 10035701 Term: Pneumonia gram-negative bacterial NOS System Organ Class: 100000004862EUCTR2008-000906-35-PTBayer AG712
进行中（未招募）
1 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative PneumoniaGram-negaive pneumoniaEUCTR2008-000906-35-CZBayer Schering Pharma AG712
进行中（未招募）
1 期
A study to test the safety and effectiveness of Bay 41-6551 as additional therapy to standard of care antimicrobial treatment in patients who have Gram-Negative Pneumonia and are intubated and mechanially ventilated.Gram-negative pneumoniaMedDRA version: 20.1Level: LLTClassification code 10035701Term: Pneumonia gram-negative bacterial NOSSystem Organ Class: 100000004862EUCTR2008-000906-35-NLBayer AG362
已完成
3 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Patients with Gram-Negative PneumoniaGram-negative Pneumonia1000401810024970NL-OMON44738Bayer9