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

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.