EUCTR2012-005280-27-SK进行中（未招募）1 期
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. - AFF006A
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- AFFiRiS AG
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients having participated in AFF006 as well as having received 6 IMP injections and having completed all visits, if not approved by the sponsor.
- •2. Written informed consent signed and dated by the patient (or her/his legal representative) and the caregiver. The patient’s capability to give informed consent has to be confirmed by an independent professional (psychiatrist, neurologist or psychologist dependent on the regulations in a given country).
- •3. Availability of a partner/caregiver knowing the patient and being able to accompany the patient at the visits and being available for the telephone interviews.
- •4. Female patients of childbearing potential are eligible if they use a medically accepted contraceptive method.
- •5. Scheduled elective hospitalization for diagnostic work-up is allowed for inclusion into the clinical trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 246
排除标准
- •1. Pregnant women.
- •2. Sexually active women of childbearing potential who are not using a medically accepted birth control method and unreliable contraception in male subjects.
- •3. Participation in the active treatment phase of another clinical trial except AFF006 within 3 months before Visit 0.
- •4. History of questionable compliance to visit schedule; patients not expected to complete the clinical trial.
- •5. Presence or history of allergy to components of the vaccine, if considered relevant by the investigator.
- •6. Contraindication for Magnetic Resonance Imaging (MRI) imaging, including but not limited to pacemakers; cochlear implants, cerebral aneurysm clips; implanted infusion pumps; implanted nerve stimulators; metallic splinters in the eye; other magnetic, electronic, or mechanical implants; or any other clinical history or examination finding that, in the judgement of the investigator, would pose a potential hazard in combination with MRI. Exceptions may apply based on the number of Microhemorrhages (MHs) at baseline of AFF006 and their number over the follow-up MRIs. To be decided after consultaion with the sponsor.
- •7. Presence and/or history of Immunodeficiency (e.g., HIV infection).
- •8. Prior and/or current treatment with experimental immunotherapeutics including Intravenous Immunoglobulin (IVIG), Alzheimer’s Disease (AD) antibody therapy and/or vaccines for AD except AD02.
- •9. Prior and/or current treatment with immunosuppressive drugs.
- •10. Treatment with benzodiazepines and/or nootropics
- •administered at high doses and/or as newly started treatment.
- •11. Treatment with anticholinergic drugs including Parkinson treatments, antidepressants (tricyclics), neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases.
研究者
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