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Also known as AAB-001
bapineuzumab · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Bapineuzumab 0.5 mg/kg | EXPERIMENTAL | infusion every 13 weeks for a total of 6 infusions |
| Placebo Control | PLACEBO_COMPARATOR | infusion every 13 weeks for a total of 6 infusions. |
| Bapineuzumab 1.0 m/kg | EXPERIMENTAL | infusion every 13 weeks for a total of 6 infusions. |
| Placebo Dose | PLACEBO_COMPARATOR | infusion every 13 weeks for a total of 6 infusions. |
| 0.15 mg/kg active bapineuzumab | EXPERIMENTAL | - |
| 0.15 mg/kg placebo | PLACEBO_COMPARATOR | - |
| 0.5 mg/kg active bapineuzumab | EXPERIMENTAL | - |
| 0.5 mg/kg placebo | PLACEBO_COMPARATOR | - |
| 1.0 mg/kg active bapineuzumab | EXPERIMENTAL | - |
| 1.0 mg/kg placebo | PLACEBO_COMPARATOR | - |
| 2.0 mg/kg active bapineuzumab | EXPERIMENTAL | - |
| 2.0 mg/kg placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Bapineuzumab 0.5 mg/kg | DRUG | infusion every 13 weeks for a total of 6 infusions |
| Placebo Control | DRUG | given by infusion every 13 weeks for a total of 6 infusions. |
| Bapineuzumab 1.0 m/kg | DRUG | infusion every 13 weeks for a total of 6 infusions |
| bapineuzumab | DRUG | IV, Q13w |
| placebo | OTHER | IV Q13w |
Inclusion Criteria: * Diagnosis of probable AD * Age from 50 to less than 89 * Mini-Mental Status Exam score of 16-26 inclusive * Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD * Stable doses of medications (cholinesterase inhibitors and memantine allowed) * Caregiv...
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Bapineuzumab was developed for the treatment of mild to moderate Alzheimer's disease. It is an investigational monoclonal antibody studied in Phase 3 clinical trials, including in ApoE4 carrier and non-carrier patient populations. It is not an approved therapy.
Bapineuzumab targets APP, the amyloid precursor protein. It is a monoclonal antibody designed to bind this target, which is relevant to the amyloid pathway in Alzheimer's disease. The drug was evaluated in biomarker-selected Alzheimer's disease populations.
Bapineuzumab was developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical development program for the drug in Alzheimer's disease.
Bapineuzumab is in Phase 3 development. It is an investigational monoclonal antibody for Alzheimer's disease and has not been approved by the FDA. All three of its listed clinical trials are completed, and none are currently active.
Bapineuzumab has been studied in three completed trials: NCT00575055 in ApoE4 carriers, NCT00574132 in ApoE4 non-carriers, and NCT00112073, a Phase 2 study. Total enrollment across these trials was 2,686 participants, with randomized, double-blind, placebo-controlled designs.