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
- Conditions
- Alzheimers diseasedementia10012272
- Registration Number
- NL-OMON38012
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
- Subject has completed all 6 infusions planned in protocol 3133K1-3000; or, if the subject was requred to temporarily suspend investigational product (e.g. because of VE), 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 VE 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 is required prior to enrollment.
- Brain MRI scan from Week 71 of study 3133K1-3000 is available for local radiology and central radiology evalutation and remains consistent with the diagnosis of AD.
- MMSE score * 10 at screening (Week 78 of 3133K1-3000).
- Continues to live at home or 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.
- In the opinion of the principal investigator, the subject and the caregiver will be compliant, and likely to participate in all scheduled evaluations.
- Any medical or psychiatric contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs, or electrocardiogram (ECG) examiniation (e.g. atrial fibrillation) that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response.
- Brain MRI scan from study 3133K1-3000 Week 71 visit indicative of any significant abnormality, including but not limited to multiple microhemorrhages (2 or more), history or evidence of a single prior hemorrhage > 1 cm3, mulitple 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).
- Use of any investiogational drugs or devices, other than bapineuzumab within the last 60 days prior to screening.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Health Outcomes Endpoints:<br /><br>To explore effect on health outcomes of long-term treatment of IV administered<br /><br>bapineuzumab in subjects with AD, using the following scales:<br /><br>* Dependence Scale (DS)<br /><br>* Resource Utilization in Dementia, version 2.4 (RUD Lite v2.4)<br /><br>* Health Utilities Index (HUI)<br /><br><br /><br>Immunogenicity:<br /><br>To explore the effect on immunogenicity of long-term treatment with IV<br /><br>administered bapineuzumab in subjects with AD, using the following scales:<br /><br>* Serum anti-bapineuzumab antibody levels.<br /><br>* In a subset of subjects, CSF anti-bapineuzumab antibody levels.<br /><br><br /><br>Biochemical characterization:<br /><br>To determine clearance characteristics of bapineuzumab product isoforms<br /><br>bapineuzumab in sera of a subset of subjects with AD, using immunoaffinity<br /><br>chromatography.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Alzheimer*s Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)<br /><br>* Disability Assessment Scale for Dementia (DAD)<br /><br>* Mini Mental State Examination (MMSE)<br /><br>* Neuropsychiatric Inventory (NPI )</p><br>