A Phase 3 Extension, Multicenter, Double-Blind, Long Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects with Alzheimer's Disease who Participated in Study ELN115727- 301 or in Study ELN115727-302
Status: Closed to Enrollment
Start Date: Jun 09 2010
End Date: OPEN
Wyeth and Janssen AI are collaborating in the development of a humanized anti-amyloid-beta (Ab) peptide monoclonal antibody, bapineuzumab (AAB-001), for the treatment of Alzheimer disease (AD). AD is characterized by the presence of an elevated burden of amyloid plaques in the brain. The predominant component of these plaques is Ab protein, particularly a 42-amino acid isoform (Ab1-42) that is derived from a larger amyloid precursor protein (APP). The hypothesis underlying this program is that administration of bapineuzumab antibody against Ab will reduce or eliminate the formation of plaque, or mediate the removal of plaque, in subjects with AD and lead to a beneficial clinical effect.
- Informed consent signed and dated by the caregiver, subject and/or by the subject’s legally acceptable representative according to local regulations.
- Must have completed all 6 infusions unless they were required to temporarily suspend study drug (eg, due to Vasogenic edema), but continued with their required visits in either Study 301 or 302, and have completed Visit 15/Week 78.
- Brain MRI scan for the Radiologist to evaluate subject safety from Study 301 or 302 at Visit 14/Week 71.
- 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 approximately 5 times per week 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 new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study.
- Screening visit brain MRI scan (ie, MRI from Study 301 or 302 V14/Week 71) indicative of any significant abnormality, including but not limited to history or evidence of a single prior hemorrhage > 1 cm3, multiple microhemorrhages (>1), or evidence of a single prior infarct > 1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions (eg, arachnoid cysts or brain tumors such as meningioma). NOTE: Subjects who have developed any of the above MRI abnormalities during Studies 301 or 302 may potentially be considered for Study 351 participation; however, approval by an unblinded Medical monitor will be required prior to enrollment. The unblinded medical monitor may exclude subjects with a history of any of the above MRI abnormalities or VE, if the MRI abnormalities, clinical findings or prior treatment assignment suggests potential safety concerns.
- Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginkgo biloba, and anticoagulants (except the use of aspirin 325 mg/day or less, Plavix, and Persantine but not for stroke).
- Subject must receive their first infusion no later than 19 weeks post Visit 13/Week 65 (last infusion) in either Study 301 or 302.
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