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

This study has been completed.
Sponsor:
Collaborator:
Grifols Biologicals Inc.
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
NCT00742417
First received: August 25, 2008
Last updated: March 8, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Biological: Albutein 5%
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albutein 5% Biological: Albutein 5%

18 Plasma Exchanges using

  • Albutein 5% (estimated 3000mL per plasma exchange) or

  • Sham Procedure

    • 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 Name: Albutein 5%

Detailed 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.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of AD (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
  • Heart diseases, including antecedents of coronary disease and heart failure. Difficult venous access precluding plasma exchange.
  • 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742417

Sponsors and Collaborators
Instituto Grifols, S.A.
Grifols Biologicals Inc.
Investigators
Principal Investigator: Merce Boada, MD Fundació ACE - Institut Català de Neurociències Aplicades, Barcelona Spain - mboada@fundacioace.com
  More Information

No publications provided

Responsible Party: Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier: NCT00742417     History of Changes
Other Study ID Numbers: IG0602
Study First Received: August 25, 2008
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Grifols Biologicals Inc.:
Alzheimer's
Dementia
Senile
Loss of cognitive abilities
Old age
Elderly
Aging
Albumin
 Caregiver
amyloid
beta amyloid
Central Nervous System Diseases
Brain Disease
Mental Disorders
Plasma Exchange

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013