NCT01561053

A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease

A Multicenter, Randomized, Controlled Study To Evaluate The Efficacy and Safety of Short-Term Plasma Exchange Followed by Long-Term Plasmapheresis With Infusion of Human Albumin Combined With Intravenous Immunoglobulin In Patients With Mild-Moderate Alzheimer's Disease

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 347 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales.

Detailed description

A clinical trial comprised of 350 subjects with probable mild to moderate Alzheimer's Disease (AD) will be conducted primarily to determine whether plasmapheresis with infusion of human albumin combined with intravenous immunoglobulin (IVIG) is able to modify patient's cognitive, functional, behavioral and global domains. There will be 3 treatment groups and 1 control group. The subjects will be randomized in a 1:1:1:1 proportion.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Albumin 5%	Therapeutic plasma exchange with human albumin 5%
BIOLOGICAL	Albumin 20%	Low volume plasma exchange with human albumin 5%
BIOLOGICAL	Immunoglobulin	Intravenous human immunoglobulin 5%

Timeline

• Start date: 2012-04-19
• Primary completion: 2018-03-06
• Completion: 2018-03-06
• First posted: 2012-03-22
• Last updated: 2019-07-31
• Results posted: 2019-07-31

Locations

40 sites across 2 countries: United States, Spain