drugset / Trial / 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
Phase 3
Completed
390 enrolled
Baxalta now part of Shire
Alzheimer's Disease Cooperative Study (ADCS) · collab
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2008-12-19
- Primary completion
- 2012-12-10
- Completion
- 2012-12-10
Outcome
Missed primary endpoint
paper No beneficial effects were observed in the dual primary outcome measures for the 2 IVIg doses tested. PMID 28381506 ↗
registry IGIV, 10% 400mg/kg vs Placebo 2 mL/kg or 4 mL/kg; p = 0.476 NCT00818662 ↗
registry IGIV, 10% 200mg/kg vs Placebo 2 mL/kg or 4 mL/kg; p = 0.530 NCT00818662 ↗
Publications
- Background Relkin N, Gessert D, Stokes K, Adamiak B, Ngo LY, Thomas R, Gelmont D, Aisen P. The Gammaglobulin Alzheimer Partnership Study (GAP): Design, screening, enrollment and futility analysis results. Alzheimer's & Dementia: The Journal of the Alzheimer's Association 8[4 Suppl], P456. 2012.
- Background Ngo L, Adamiak B, Gelmont D. A confirmatory phase 3 randomized, double-blind, placebo-controlled study of the safety and effectiveness of immune globulin intravenous (human), 10% solution (Gammagard Liquid/Kiovig) for the treatment of mild to moderate Alzheimer's Disease. Poster Presentation: Alzheimer's Association International Conference on Alzheimer's Disease (ICAD), Paris, France July 16-21 2011.
- Relkin NR, Thomas RG, Rissman RA, Brewer JB, Rafii MS, van Dyck CH, Jack CR, Sano M, Knopman DS, Raman R, Szabo P, Gelmont DM, Fritsch S, Aisen PS; Alzheimer's Disease Cooperative Study. A phase 3 trial of IV immunoglobulin for Alzheimer disease. Neurology. 2017 May 2;88(18):1768-1775. doi: 10.1212/WNL.0000000000003904. Epub 2017 Apr 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 200 mg/kg | Intravenous |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 400 mg/kg | Intravenous |