NCT01097096已完成2 期
A 90-week, Multi-center, Randomized, Double-blind, Placebo-controlled Study in Patients With Mild Alzheimer's Disease (AD) to Investigate the Safety, Tolerability and Abeta-specific Antibody Response Following Repeated i.m. Injections of Adjuvanted CAD106
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 31
- 主要终点
- Safety and tolerability assessments (physical/neurological examinations, electrocardiogram (ECG), vital signs, standard and special laboratory evaluations, Magnetic Resonance Imaging (MRIs), Adverse events / Serious adverse events (AE/SAE) monitoring).
研究概览
简要总结
This study will assess the safety, tolerability and Abeta-specific antibody response of repeated intra-muscular injections of adjuvanted 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
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and/or female patients below 85 years of age (inclusive)
- •Diagnosis of mild Alzheimer's Disease
- •Mini-Mental State Examination (MMSE) 20 to 26 (inclusive) at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 4 weeks prior to clinical assessments
排除标准
- •Previously participated in an AD vaccine study and received active treatment
- •History or presence of an active autoimmune disease
- •History or presence of seizure disorder
- •Presence of significant coronary heart disease 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, tolerability and pharmacodynamic assessments of the patient
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
CAD106 450μg + either Adjuvant 1 or 2 at low dose
Active Comparator
干预措施: CAD106 (Biological)
CAD106 150μg + Adjuvant 1 at middle dose
Active Comparator
干预措施: MF59 (Biological)
CAD106 150μg + Adjuvant 2 at low dose
Active Comparator
干预措施: CAD106 (Biological)
Placebo + Adjuvant 2 at middle dose
Placebo Comparator
干预措施: Placebo (Biological)
CAD106 450μg + either Adjuvant 1 or 2 at middle dose
Active Comparator
干预措施: Alum (Biological)
CAD106 450μg + either Adjuvant 1 or 2 at low dose
Active Comparator
干预措施: Alum (Biological)
Placebo + either Adjuvant 1 or 2 at middle dose
Placebo Comparator
干预措施: Placebo (Biological)
Placebo + Adjuvant 1 at middle dose
Placebo Comparator
干预措施: Placebo (Biological)
CAD106 150μg + Adjuvant 2 at middle dose
Active Comparator
干预措施: MF59 (Biological)
CAD106 150μg + Adjuvant 2 at middle dose
Active Comparator
干预措施: CAD106 (Biological)
CAD106 150μg + Adjuvant 1 at low dose
Active Comparator
干预措施: MF59 (Biological)
CAD106 150μg + Adjuvant 1 at low dose
Active Comparator
干预措施: CAD106 (Biological)
CAD106 150μg + Adjuvant 1 at middle dose
Active Comparator
干预措施: CAD106 (Biological)
CAD106 450μg + either Adjuvant 1 or 2 at low dose
Active Comparator
干预措施: MF59 (Biological)
CAD106 450μg + either Adjuvant 1 or 2 at middle dose
Active Comparator
干预措施: MF59 (Biological)
CAD106 450μg + either Adjuvant 1 or 2 at middle dose
Active Comparator
干预措施: CAD106 (Biological)
CAD106 150μg + Adjuvant 2 at low dose
Active Comparator
干预措施: MF59 (Biological)
结局指标
主要结局
Safety and tolerability assessments (physical/neurological examinations, electrocardiogram (ECG), vital signs, standard and special laboratory evaluations, Magnetic Resonance Imaging (MRIs), Adverse events / Serious adverse events (AE/SAE) monitoring).
时间窗: Screening and through the end of the study to Week 90
次要结局
- Amyloid beta (Aβ)-specific and Qβ carrier-specific antibody response to CAD106 (with either adjuvant) in serum and cerebrospinal fluid (CSF)(Screening and through the end of the study to Week 90)
- Amyloid beta (Aβ)-specific and Qβ carrier-specific T-cell response to CAD106 (with either adjuvant) using peripheral blood mononuclear cells (PBMCs)(Screening and at week 8)
- Changes over time of the concentrations of disease related markers (Aβ1-40 and Aβ1-42 in plasma; Aβ1-40, Aβ1-42, total-tau, phospho-tau in CSF, or other markers) in patients with mild AD receiving CAD106 (with either adjuvant) compared to placebo(Screening and through the end of the study to Week 90)
研究者
研究点 (31)
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