NCT00795418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
- 31
- 试验地点
- 10
- 主要终点
- Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI)
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 mid 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
- •Male and/or female patients between 40 and 85 years of age (both inclusive)
- •Diagnosis of mild Alzheimer's Disease (AD)
- •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 other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
- •Advanced, severe, progressive or unstable disease that might interfere with the safety of the patient.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
CAD106
Experimental
干预措施: CAD106 (Biological)
结局指标
主要结局
Safety/tolerability of repeated injection of CAD106 at multiple timepoints including but not limited to screening, baseline and through the end of the study (adverse events, physical/neurologic exams, vital signs, 12- lead ECGs, clinical labs, brain MRI)
时间窗: 52 weeks
次要结局
- Immune response at multiple timepoints including but not limited to screening, baseline and through the end of the study.(52 weeks)
- Functional assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.(52 weeks)
- Cognitive assessments at multiple timepoints including but not limited to screening, baseline and through the end of the study.(52 weeks)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
2 期
Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.Alzheimer DiseaseNCT00733863Novartis27
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