A Randomized, Controlled, Parallel Group, Double-blind, Multi-center, Phase II Study to Assess the Clinical- and Immunological Activity,as Well as the Safety and Tolerability of Different Doses/Formulations of AFFITOPE AD02 Administered Repeatedly to Patients With Early Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Affiris AG
- 入组人数
- 335
- 试验地点
- 31
- 主要终点
- cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)
研究概览
简要总结
This is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. Patients will be randomized to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.
详细描述
AFFITOPE AD02 is a second generation AD immunotherapeutics targeting Aβ. Its active component is a synthetic peptide functionally mimicking the unmodified N-terminus of Aβ.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent capability
- •Early AD, based on episodic memory deficit and hippocampal atrophy
- •Age from 50 to 80, inclusive
- •MMSE of 20+
- •Brain magnetic resonance imaging scan consistent with the diagnosis of AD
- •Stable doses of medications (cholinesterase inhibitors and memantine allowed)
- •Caregiver able to attend all visits with patient
排除标准
- •Significant neurological disease other than AD
- •Major psychiatric illness
- •Significant systemic illness
- •Autoimmune disease
- •Prior treatment with experimental immunotherapeutics for AD including IVIG
- •Women of childbearing potential without birth control
- •Contraindication for MRI scan
研究组 & 干预措施
A: AFFITOPE AD02
干预措施: active: AFFITOPE AD02 (Biological)
B: AFFITOPE AD02
干预措施: active: AFFITOPE AD02 (Biological)
C: AFFITOPE AD02
干预措施: active: AFFITOPE AD02 (Biological)
D: Placebo control
干预措施: control: Placebo (Biological)
结局指标
主要结局
cognitive(ADAS-cog modified) and functional(ADCS-ADL modified)
时间窗: 18 months
次要结局
- cognitive(computerised test battery), global(CDR-sb), behavioral(NPI), biomarker (volumetric MRI)(18 months)