EUCTR2012-004763-45-ES进行中（未招募）1 期
Randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study of Lu AE58054 in patients with mild-moderate Alzheimer?s disease treated with donepezil; study 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 930
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
- •? The patient has a knowledgeable and reliable caregiver.
- •? The patient is an outpatient.
- •? The patient has probable AD.
- •? The patient has mild to moderate AD.
- •? Stable treatment with donepezil.
- •? The patient, if a woman, must have had her last natural menstruation ?24 months prior to baseline, OR be surgically sterile.
- •? The patient, if a man, agrees to protocol-defined use of effective
- •contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit.
- •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 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 790
排除标准
- •? The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.
- •? The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.
- •? The patient has evidence of clinically significant disease.
- •? The patient's donepezil therapy is likely to be interrupted or discontinued during the study.
- •? The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.
研究者
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