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

Study Overview
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Brief Summary
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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.

Official Title
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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 Study ELN115727-302.

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Bapineuzumab


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 51 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bapineuzumab 0.5 mg/kg<br>0.5 mg/kg | Drug: Bapineuzumab<br>* 0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years. 1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.<br>|
| Active Comparator: Bapineuzumab 1.0 mg/kg<br>1.0 mg/kg | Drug: Bapineuzumab<br>* 0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years. 1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments. |  | Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD. |  | The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild to moderate Alzheimer's disease