EUCTR2009-015079-29-SK进行中（未招募）1 期
A Phase 3 Extension, Multicenter, Double-blind, Parallel-Group, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E e4 Noncarriers and Participated in Study 3133K1-3000-WW
Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola road, Collegeville, PA 19426 USA0 个研究点目标入组 1,000 人开始时间: 2010年2月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
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. Signed and dated written informed consent obtained from the subject or the subject’s legally acceptable representative (if applicable) in accordance with the local regulations. The subject’s caregiver must also consent to participate in the study.
- •2. Subject has completed all 6 infusions planned in protocol 3133K1-3000; or, if the subject was required to temporarily suspend investigational product (e.g., due to vasogenic edema, adverse event, study suspension), he/she continued with required visits, has completed all study visits through the week 78 visit and his/her current status indicates that he/she resumed or is eligible to resume investigational product.
- •NOTE: Subjects who developed vasogenic edema during study 3133K1-3000 may be considered for study 3133K1-3002 participation if the abnormality is resolved and the subject met criteria to resume investigational product. Medical monitor approval to resume investigational product infusions is required prior to enrollment.
- •3. Brain MRI scan from Week 71 of study 3133K1-3000 is available for local radiology and central radiology evaluation and remains consistent with the diagnosis of AD.
- •4. MMSE score =10 at screening (Week 78 of 3133K1-3000).
- •5. Continues to live at home or is community dwelling with appropriate caregiver capable of accompanying the subject on all clinic visits and visiting with the subject at least 5 days per week, on average for the duration of the study.
- •6. In the opinion of the principal investigator, the subject and the caregiver will be compliant, and likely to participate in all scheduled evaluations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 790
排除标准
- •1. Any medical or psychiatric contraindication (e.g. suicidal ideation/behaviour) or clinically significant abnormality on physical, neurological, laboratory, vital signs or electrocardiogram (ECG) examination (e.g., atrial fibrillation) that in the investigator's judgement will significantly increase the risk associated with the subject's participation in, and competion of the study, or could preclude the evaluation of the subject’s response.
- •2. Brain MRI scan from study 3133K1-3000 Week 71 visit indicative of any significant abnormality, including but not limited to more than 4 microhemorrhages (<10mm), history or evidence of a single prior hemorrhage > 1 cm3, multiple lacunar infarct (2 or more) or evidence of a single prior infarct > 1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions (e.g., arachnoid cysts or brain tumors such as meningioma).
- •3. Use of any investigational drugs or devices, other than bapineuzumab, within the last 60 days prior to screening.
- •4. Current use of herbal preparations containing ginkgo biloba, or use of anticoagulants.
- •NOTE: Platelet anti-aggregants (e.g., aspirin 325 mg/day or less, clopidogrel bisulfate, dipyridamole for indications other than stroke) are allowed.
研究者
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