NCT00733863已完成2 期
A 52-week,Multi-center,Randomized,Double-blind,Placebo-controlled,Parallel Group Study in Patients With Mild Alzheimer's Disease to Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
研究概览
简要总结
This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild 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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Mild Alzheimer's Disease
- •Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks
排除标准
- •Previously participated in an AD vaccine study and received active treatment
- •History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
- •History or presence of seizures and/or cerebrovascular disease.
- •Presence of an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Biological)
1
Experimental
干预措施: CAD106 (Biological)
结局指标
主要结局
Safety/tolerability assessments at multiple timepoints including but not limited to screening, baseline, and through the end of the study to Week 52.
时间窗: 52 weeks
次要结局
- Immune response, cognitive and functional assessments at multiple timepoints including but not limited to baseline and through the end of the study to Week 52.(52 weeks)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's PatientsAlzheimer's DiseaseNCT00795418Novartis31
已完成
2 期
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's PatientsAlzheimer DiseaseNCT00956410Novartis21
已完成
2 期
To Investigate the Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Alzheimer's PatientsAlzheimer DiseaseNCT01023685Novartis24
终止
2 期
Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusNCT00732940Human Genome Sciences Inc.56
终止
2 期
A Study to Evaluate the Safety and Tolerability of MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Participants With Moderate to Severe Atopic DermatitisAtopic DermatitisNCT03864627Galapagos NV33