drugset / Trial / NCT01736579
Long-Term Study of IGIV, 10% in Alzheimer´s Disease
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.
Timeline
- Start
- 2012-11-29
- Primary completion
- 2013-06-04
- Completion
- 2013-06-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 0.2 g/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 0.4 g/kg | Intravenous |