CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 390 enrolled
Drug / intervention
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg +3 morebiological
Likely dose
Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00818662
NCT00818662Phase 3Completed
CompareCT.gov

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

Baxalta now part of Shire·interventional·Posted Jan 8, 2009·Updated May 19, 2021

In Brief

A Phase 3 clinical trial evaluating Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg, Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg, and 2 other interventions for Alzheimer´s Disease. Completed, enrolled 390 participants across 41 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer´s Disease
CountriesCanada, United States
CollaboratorsAlzheimer's Disease Cooperative Study (ADCS)

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 8, 2009
Enrollment StartDec 19, 2008
Primary CompletionDec 10, 2012
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 17.5 years ago

Interventions

Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kgbiological

400 mg/kg bodyweight every 2 weeks for 70 weeks

Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kgbiological

200 mg/kg bodyweight every 2 weeks for 70 weeks

Placebo solution: Human Albumin 0.25% - 4 mL/kgbiological

Placebo solution: 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks

Placebo solution: Human Albumin 0.25% - 2 mL/kgbiological

Placebo solution: 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks