Efficacy and Safety of Plasma Exchange With 5% Albutein in Beta-Amyloid Peptide Clearance in Cerebrospinal Fluid

Alzheimer's Disease Clinical Trial

Official title: A Phase II Study to Evaluate the Efficacy and Safety of Plasma Exchange With 5% Albutein in Beta-Amyloid Peptide Clearance in Cerebrospinal Fluid, and Its Effects in Patients With Mild-Moderate Alzheimer's Disease

Status Completed

Clinical Trial Summary

The purpose of this study is 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.

Clinical Trial Description

A phase II study comprised of 42 subjects (21 per group) with probable mild to moderate AD will be 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 the treatment group of patients with AD.

• There will be two weeks for screening and randomization of both groups (treatment and control).

• The subjects will be randomized in a 1:1 proportion.

• After screening and randomization, treatment will proceed 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 will follow the same program, except for the plasma exchanges.

• After the treatment period ends, subjects will be 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. A total of 42 subjects are to be enrolled in the study with just 10 subjects in the US. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

• NCT number: NCT00742417
• Study type: Interventional
• Source: Grifols Biologicals Inc.
• Status: Completed
• Phase: Phase 2
• Start date: April 2009
• Completion date: March 2011