Status:
TERMINATED
A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborating Sponsors:
Pfizer
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
51+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ...
Eligibility Criteria
Inclusion
- Diagnosis of probable AD
- Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)
- Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71
- Caregiver able to attend all clinic visits with patient
Exclusion
- 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 (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment
- Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
896 Patients enrolled
Trial Details
Trial ID
NCT00937352
Start Date
July 1 2009
End Date
September 1 2012
Last Update
December 20 2013
Active Locations (191)
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1
University of Alabama Hospital
Birmingham, Alabama, United States, 35205
2
Dedicated Clinical Research, Inc.
Goodyear, Arizona, United States, 85395
3
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
4
HOPE Research Institute, LLC
Phoenix, Arizona, United States, 85050