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

NCT ID: NCT00742417

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Albutein 5%

Patients allocated to this arm underwent plasma exchange with Albutein 5%.

Group Type: EXPERIMENTAL

Albutein 5%

Intervention Type: BIOLOGICAL

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

Control

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)

Interventions

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

Intervention Type: BIOLOGICAL

Control

Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• A diagnosis of AD ( National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association [NINCDS-ADRDA] criterion), and Mini-mental Status Examination (MMSE) score between ≥18 and ≤26.
• Current stable treatment with acetylcholine esterase inhibitors (AChEIs) for the previous three months.
• A stable care taker must be available, and must attend the patient study visits.
• The patient and a close relative or legal representative must read the patient information sheet, agree to participation in the trial, and then sign the informed consent document (the patient personally and the close relative/legal representative).
• The patient must be able to follow the study protocol, receive the treatment in the established time period, and continue during the follow-up interval.
• A brain Computed Axial Tomography (CAT) or Magnetic Resonance Imaging (MRI) study, obtained in the 12 months prior to recruitment, showing the absence of cerebrovascular disease, must be available.

Exclusion Criteria

• Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters
• A history of frequent adverse reactions (serious or otherwise) to blood products.
• Hypersensitivity to albumin or allergies to any of the components of Albutein 5% Human Albumin.
• Plasma creatinine > 2 mg/dL.
• Uncontrolled high blood pressure.
• Liver cirrhosis or any liver problem with alanine aminotransferase (GPT) > 2.5 x upper limit of normal (ULN), or bilirubin > 2 mg/dL.
• Heart diseases, including antecedents of coronary disease and heart failure.
• Difficult venous access precluding plasma exchange.
• Participation in other clinical trials, or the reception of any other investigational drug in the three months prior to the start of the study.
• Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, toxic habits, etc.).
• Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.
• Fewer than six years of education.
• Prior behavioral disorders requiring pharmacological treatment, including insomnia.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grifols Biologicals, LLC

INDUSTRY

Sponsor Role: collaborator

Instituto Grifols, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merce Boada, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació ACE

Laura Núñez

Role: STUDY_DIRECTOR

Grifols Biologicals, LLC

Antonio Paez

Role: STUDY_CHAIR

Grifols Biologicals, LLC

Locations

Howard University

Washington D.C., District of Columbia, United States

Mid-Atlantic Geriatric/ARC

Whiting, New Jersey, United States

Fundació ACE

Barcelona, Catalonia, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Madrid, Spain

Countries

United States; Spain

Other Identifiers

IG0602

Identifier Type: -

Identifier Source: org_study_id