drugset / Trial / NCT00112073
AAB-001 in Patients With Mild to Moderate Alzheimer's Disease
Phase 2
Completed
234 enrolled
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).
Timeline
- Start
- 2005-04
- Primary completion
- 2008-11
- Completion
- 2008-12
Publications
- Arrighi HM, Barakos J, Barkhof F, Tampieri D, Jack C Jr, Melancon D, Morris K, Ketter N, Liu E, Brashear HR. Amyloid-related imaging abnormalities-haemosiderin (ARIA-H) in patients with Alzheimer's disease treated with bapineuzumab: a historical, prospective secondary analysis. J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):106-12. doi: 10.1136/jnnp-2014-309493. Epub 2015 Feb 10.
- Blennow K, Zetterberg H, Rinne JO, Salloway S, Wei J, Black R, Grundman M, Liu E; AAB-001 201/202 Investigators. Effect of immunotherapy with bapineuzumab on cerebrospinal fluid biomarker levels in patients with mild to moderate Alzheimer disease. Arch Neurol. 2012 Aug;69(8):1002-10. doi: 10.1001/archneurol.2012.90.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | bapineuzumab | Monoclonal antibody | 0.15 mg/kg | Intravenous |
| Subject | bapineuzumab | Monoclonal antibody | 0.5 mg/kg | Intravenous |
| Subject | bapineuzumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | bapineuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |