EUCTR2012-004764-22-PT进行中（未招募）1 期
Randomised, double-blind, parallel-group, placebo-controlled,fixed-dose study of Lu AE58054 in patientswith mild-moderate Alzheimer’s disease treated withdonepezil; Study 2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 840
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 126
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 714
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
相似试验
进行中（未招募）
1 期
Randomised, double-blind, parallel-group, placebo-controlled, duloxetine referenced, dose-finding study of Lu AA24530 in Major Depressive DisorderMedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depressionMajor Depressive DisorderEUCTR2007-001071-11-SEH. Lundbeck A/S625
进行中（未招募）
1 期
Study of Lu AE58054 in Patients with Mild-moderate Alzheimer's disease treated with DonepezilAlzheimer´s DiseaseMedDRA version: 17.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852EUCTR2012-004764-22-HRH. Lundbeck A/S840
进行中（未招募）
1 期
Randomised, double-blind, parallel-group, placebo-controlled, duloxetine-referenced, fixed dose study comparing the efficacy and safety of Lu AA21004 in acute treatment of major depressive disorder in elderly patients - Not applicableEUCTR2008-002901-38-FIH. Lundbeck A/S450
进行中（未招募）
1 期
Study of Lu AE58054 in Patients With Mild-moderate Alzheimer's Disease Treated With DonepezilAlzheimer?s diseaseMedDRA version: 16.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852EUCTR2012-004763-45-ESH. Lundbeck A/S930
进行中（未招募）
不适用
Randomised, double-blind, parallel-group, placebo-controlled, fixed-dose comparison study of escitalopram in combination with two fixed doses of gaboxadol to escitalopram in Major Depressive DisorderMedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSMajor Depressive DisorderEUCTR2008-000506-36-ATH. Lundbeck A/S500