Study Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
Summary
This is a study to evaluate the efficacy and safety of multiple doses of bapineuzumab in patients with mild to moderate Alzheimer Disease. Patients will receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.
Timeline
- Start
- 2008-06
- Primary completion
- 2012-10
- Completion
- 2013-08
Outcome
Missed primary endpoint
Stopped: “The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.”
paper The current trials showed no significant difference between bapineuzumab and placebo for the coprimary endpoints PMID 27176461 ↗
registry Bapineuzumab 0.5 mg/kg vs Placebo; p = 0.057; Mean Difference (Final Values) -1.83 (95% CI -3.71 to 0.05) NCT00667810 ↗
registry Bapineuzumab 0.5 mg/kg vs Placebo; p = 0.459; Mean Difference (Final Values) 1.51 (95% CI -2.48 to 5.49) NCT00667810 ↗
Publications
- Vandenberghe R, Rinne JO, Boada M, Katayama S, Scheltens P, Vellas B, Tuchman M, Gass A, Fiebach JB, Hill D, Lobello K, Li D, McRae T, Lucas P, Evans I, Booth K, Luscan G, Wyman BT, Hua L, Yang L, Brashear HR, Black RS; Bapineuzumab 3000 and 3001 Clinical Study Investigators. Bapineuzumab for mild to moderate Alzheimer's disease in two global, randomized, phase 3 trials. Alzheimers Res Ther. 2016 May 12;8(1):18. doi: 10.1186/s13195-016-0189-7.
- Lacey L, Bobula J, Rudell K, Alvir J, Leibman C. Quality of Life and Utility Measurement in a Large Clinical Trial Sample of Patients with Mild to Moderate Alzheimer's Disease: Determinants and Level of Changes Observed. Value Health. 2015 Jul;18(5):638-45. doi: 10.1016/j.jval.2015.03.1787. Epub 2015 Apr 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | bapineuzumab | Monoclonal antibody | 0.5 mg/kg | Intravenous |
| Subject | bapineuzumab | Monoclonal antibody | 1 mg/kg | Intravenous |