A Phase 3 Extension, Multicenter, Long-term Safety and Tolerability Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer Disease Who Are Apolipoprotein E ε4 Carriers and Participated in Study 3133K1-3001-WW
- Conditions
- 10012272Alzheimers disease
- Registration Number
- NL-OMON38076
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Subject has completed all 6 infusions planned in protocol 3133K1-3001; or, if the subject
was required 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 3133K1-3001 may be considered for
study 3133K1-3003 participation if the abnormality is resolved and the subject met
criteria to resume investigational product. Medical monitor approval is required prior to enrrollment.
2. Brain MRI scan from Week 71 of study 3133K1-3001 is available for local radiology and
central radiology evaluation and remains consistent with the diagnosis of AD.
3. MMSE score *10 at screening (Week 78 of 3133K1-3001).
4. 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.
5. In the opinion of the principal investigator, the subject and the caregiver will be
compliant, and likely to participate in all scheduled evaluations.
1. Any medical or psychiatric contraindication or clinically significant abnormality on
physical, neurological, laboratory, vital signs, or electrocardiogram (ECG) examination
(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.
2. Brain MRI scan from study 3133K1-3001 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, 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, or
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. To explore effect on health outcomes of long-term<br /><br>treatment of IV administered bapineuzumab in subjects with AD, using the<br /><br>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. To explore the effect on immunogenicity of long-term treatment<br /><br>with IV administered bapineuzumab in subjects with AD, using the following<br /><br>scales:<br /><br>* Serum anti-bapineuzumab antibody levels.<br /><br>* In a subset of subjects, CSF anti-bapineuzumab antibody levels.<br /><br><br /><br>Pharmacokinetics: To determine clearance characteristics of bapineuzumab<br /><br>product isoforms bapineuzumab in sera of a subset of subjects with AD, using<br /><br>biochemical characterization with immunoaffinity 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>