A Long-Term Safety And Tolerability Extension Study Of Bapineuzumab In Alzheimer Disease Patients

Phase 3 Terminated 494 enrolled Pfizer

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3001(NCT00676143). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

Timeline

Start: 2009-12
Primary completion: 2012-10
Completion: 2012-11

Outcome

Outcome not reported

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.”

Publications

Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	bapineuzumab	Monoclonal antibody	0.5 mg/kg	Intravenous