NCT01736579

Long-Term Study of IGIV, 10% in Alzheimer´s Disease

A Study of the Long-Term Safety and Efficacy of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) in Mild to Moderate Alzheimer´s Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 51 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer´s Disease

Interventions

Type	Name	Description
DRUG	Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

Timeline

• Start date: 2012-11-29
• Primary completion: 2013-06-04
• Completion: 2013-06-04
• First posted: 2012-11-29
• Last updated: 2021-05-19
• Results posted: 2016-08-23

Locations

1 site across 1 country: United States