A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

• Status: Terminated
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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 ELN115727-302.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
• Collaborator: Pfizer

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)