drugset / Trial / NCT00916617

Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab

NCT00916617 ↗

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo.

Timeline

Start
2009-06
Primary completion
2012-09
Completion
2012-09

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.”

Drugs

EvaluationDrugModalityDoseRoute
Subject bapineuzumab Monoclonal antibody 5 mg Subcutaneous

Indications