NCT00818662

A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease

A Randomized, Double-Blind, Placebo-Controlled, Two Dose Arm, Parallel Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 50 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy and safety of 2 doses of Immune Globulin Intravenous (IGIV), 10% administered every 2 weeks as an intravenous (IV) infusion compared with placebo in participants with mild to moderate Alzheimer's disease (AD).

Detailed description

Study visits: Each participant will be tested at the investigational site, and if qualified, will be treated intravenously (through a vein) every two weeks for 70 weeks (approximately 18 months). The first three infusions must be done at the site, but if the infusions are well tolerated, subsequent infusions may be done by a qualified healthcare provider in the home or other suitable location. Each participant must return to the site every 3 months for evaluation of cognition as well as blood tests and scans of the brain.

Conditions

• Alzheimer´s Disease

Interventions

Type	Name	Description
BIOLOGICAL	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg	400 mg/kg bodyweight every 2 weeks for 70 weeks
BIOLOGICAL	Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg	200 mg/kg bodyweight every 2 weeks for 70 weeks
BIOLOGICAL	Placebo solution: Human Albumin 0.25% - 4 mL/kg	Placebo solution: 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks
BIOLOGICAL	Placebo solution: Human Albumin 0.25% - 2 mL/kg	Placebo solution: 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks

Timeline

• Start date: 2008-12-19
• Primary completion: 2012-12-10
• Completion: 2012-12-10
• First posted: 2009-01-08
• Last updated: 2021-05-19
• Results posted: 2014-10-28

Locations

41 sites across 2 countries: United States, Canada