EUCTR2012-004299-20-ES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 updated National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA; 'McKhann II') Criteria.
- •-Has an MMSE score of 10 to 21 (inclusive) at the Screening Visit.
- •-Has clinically significant agitation/aggression defined as NPI agitation/aggression subscore of >= 4, with a severity score of >= 2 at both the Screening and Baseline Visits.
- •-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 symptoms of psychosis (delusion or hallucinations) that require treatment with antipsychotics or psychiatric hospitalization.
- •-Treated with oral antipsychotic medications within 2 weeks prior to the Screening Visit.
- •-Treated with depot preparations of an antipsychotic within 3 months of the Screening Visit.
- •-Has Screening Visit brain MRI scan abnormalities that can be attributed to diseases or processes other than AD.
研究者
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