A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Affiris AG
- 入组人数
- 194
- 试验地点
- 27
- 主要终点
- Composite Measures of Primary Safety and Tolerability Endpoints
研究概览
简要总结
This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients having participated in AFF006+having received 6 investigational medicinal product (IMP) injections+having completed all visits
- •Written informed consent
- •Availability of a partner/caregiver
- •Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
- •Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial.
排除标准
- •Pregnant women.
- •Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.
- •Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit
- •History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
- •Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
- •Contraindication for MRI imaging
- •Presence and/or history of immunodeficiency (e.g., HIV infection).
- •Prior and/or current treatment with experimental immunotherapeutics including Intravenous immunoglobulin (IVIG), AD antibody therapy and/or vaccines for AD except AD
- •Prior and/or current treatment with immunosuppressive drugs.
- •Treatment with benzodiazepines and/or nootropics administered at high doses and/or as newly started treatment.
- •Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.
研究组 & 干预措施
Group 1
AFF006 Placebo groups receive 6 AFFITOPE® AD02 vaccinations
干预措施: AFFITOPE® AD02 (Biological)
Group 2
AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations
干预措施: AFFITOPE® AD02 (Biological)
Group 2
AFF006 verum groups receive 3 Placebo injections then followed by 3 AFFITOPE® AD02 vaccinations
干预措施: Placebo (Biological)
结局指标
主要结局
Composite Measures of Primary Safety and Tolerability Endpoints
时间窗: 19 months
* Withdrawal criteria * Number of Adverse events (AEs) * Number of any serious adverse events (SAE) * Alzheimer's Disease Assessment Scale - Cognition (ADAScog) * Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL)
次要结局
- Composite Measures of Secondary Efficacy Endpoints(19 months)