Efficacy and Safety of Plasma Exchange With 5% Albutein in Beta-Amyloid Peptide Clearance in Cerebrospinal Fluid
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- 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 Alzheimer's disease (AD). [ Time Frame: 1 year - approx. ] [ Designated as safety issue: No ]
- To assess the variations in other parameters (tau protein, beta-secretase, gamma-secretase, nicastrin, etc.). - To determine whether plasma exchange with 5% human albumin is able to modify the plasma concentration of beta-amyloid. [ Time Frame: 1 year - approx. ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
|Experimental: Albutein 5%||
Biological: Albutein 5%
18 Plasma Exchanges using
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742417
|Principal Investigator:||Merce Boada, MD||Fundació ACE - Institut Català de Neurociències Aplicades, Barcelona Spain - firstname.lastname@example.org|