A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
Status and phase
Terminated
Phase 3
Conditions
Alzheimer's Disease
Treatments
Drug: Bapineuzumab
Details and patient eligibility
About
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.
Enrollment
896 patients
Sex
All
Ages
51+ years old
Volunteers
No Healthy Volunteers
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)
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
896 participants in 2 patient groups
Bapineuzumab 0.5 mg/kg
Active Comparator group
Description:
0.5 mg/kg
Treatment:
Drug: Bapineuzumab
Bapineuzumab 1.0 mg/kg
Active Comparator group
Description:
1.0 mg/kg
Treatment:
Drug: Bapineuzumab
Trial contacts and locations
191
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2026 Veeva Systems