NCT00742417

Efficacy and Safety of Plasma Exchange With 5% Albumin in Beta-amyloid Peptide Clearance in Cerebral Spinal Fluid

Phase II Study to Evaluate the Efficacy and Safety of Plasma Exchange With 5% Albumin in Beta-amyloid Peptide Clearance in Cerebral Spinal Fluid, and Its Effects in Patients With Mild-moderate Alzheimer's Disease.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy and safety of plasma exchange with 5% albumin in beta-amyloid peptide clearance in cerebrospinal fluid, and its effects in patients with mild-moderate Alzheimer's disease.

Detailed description

A phase II study was conducted primarily to determine whether plasma exchange with 5% human albumin is able to modify the concentration of beta-amyloid peptide in cerebrospinal fluid (CSF) in patients with AD. * There was two weeks for screening and randomization of both groups (treatment and control). * The subjects were randomized in a 1:1 proportion. After screening and randomization, treatment proceeded as follows: * three weeks of intensive treatment with two plasma exchanges per week * followed by a month and a half of maintenance treatment with one weekly plasma exchange, and * finally, three months of treatment with one plasma exchange every two weeks. The control group followed the same program, except for the plasma exchanges. After the treatment period ended, subjects followed-up for a 6-month period of time. The trial comprises a global multicenter (Spain and US), blind, randomized, controlled design. The trials key coordination is based in Spain where Dr. Boada (see Study Officials/Investigators) is the main study official.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Albutein 5%	18 Plasma Exchanges using Albutein 5%: * three weeks of intensive treatment with two plasma exchanges per week * six weeks of maintenance treatment with one weekly plasma exchange * three months of maintenance treatment with one plasma exchange every two weeks
OTHER	Control	Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)

Timeline

• Start date: 2007-07-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2008-08-27
• Last updated: 2016-06-14
• Results posted: 2016-06-14

Locations

4 sites across 2 countries: United States, Spain