Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease

Phase 2 Completed 58 enrolled Octapharma

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study evaluated the effect of 6 or 12 infusions of different doses of octagam (intravenous immunoglobulin \[IVIG\]) 10% on the reduction of amyloid beta peptide (Aβ) in cerebral spinal fluid (CSF) and on the increase of Aβ in blood plasma in patients with mild to moderate Alzheimer's disease.

Timeline

Start: 2009-02
Primary completion: 2010-09
Completion: 2010-09

Publications

Dodel R, Rominger A, Bartenstein P, Barkhof F, Blennow K, Forster S, Winter Y, Bach JP, Popp J, Alferink J, Wiltfang J, Buerger K, Otto M, Antuono P, Jacoby M, Richter R, Stevens J, Melamed I, Goldstein J, Haag S, Wietek S, Farlow M, Jessen F. Intravenous immunoglobulin for treatment of mild-to-moderate Alzheimer's disease: a phase 2, randomised, double-blind, placebo-controlled, dose-finding trial. Lancet Neurol. 2013 Mar;12(3):233-43. doi: 10.1016/S1474-4422(13)70014-0. Epub 2013 Jan 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	0.1 g/kg	Intravenous
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	0.2 g/kg	Intravenous
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	0.25 g/kg	Intravenous
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	0.4 g/kg	Intravenous
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	0.5 g/kg	Intravenous
Subject	Immune Globulin Intravenous (Human)	Protein / enzyme biologic	0.8 g/kg	Intravenous

Study of Octagam (Intravenous Immunoglobulin [IVIG]) 10% on the Treatment of Mild to Moderate Alzheimer's Disease

Summary

Timeline

Publications

Drugs

Indications