NCT00812565

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

Prospective 24-week, Double-blind, Randomised, Placebo-controlled, Multicenter Study Evaluating Safety and Change in Efficacy-related Surrogate Parameters in Patients With Dementia of the Alzheimer's Type Under Treatment With Increasing Dosages of Intravenous Immunoglobulin (Octagam 10%)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Octapharma · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants received 12 infusions of 0.1 g/kg, 0.25 g/kg, or 0.4 g/kg body weight octagam 10% at 2-week intervals (±3 days) or 6 infusions of 0.2 g/kg, 0.5 g/kg, or 0.8 g/kg body weight octagam 10% at 4-week intervals (±5 days). The effect of the infusions on the reduction of Aβ peptide in CSF and the increase of Aβ peptide in blood plasma was evaluated.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Placebo	Commercially available 0.9% isotonic sodium chloride solution.
BIOLOGICAL	octagam 10%	octagam 10% was supplied as ready-to-use solutions of human immunoglobulin.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-12-22
• Last updated: 2014-05-05
• Results posted: 2014-05-05

Locations

1 site across 1 country: United States