drugset / Trial / NCT00916617
Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab
Phase 2
Terminated
62 enrolled
Pfizer
JANSSEN Alzheimer Immunotherapy Research & Development, LLC · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | bapineuzumab | Monoclonal antibody | 5 mg | Subcutaneous |