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A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease (AMBAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Grifols Biologicals Inc.
Grifols Biologicals Inc.
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. ) Identifier:
First received: March 16, 2012
Last updated: June 15, 2015
Last verified: June 2015
The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales.

Condition Intervention Phase
Alzheimer's Disease
Biological: Albumin
Biological: Immune globulin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Controlled Study To Evaluate The Efficacy and Safety of Short-Term Plasma Exchange Followed by Long-Term Plasmapheresis With Infusion of Human Albumin Combined With Intravenous Immunoglobulin In Patients With Mild-Moderate AD

Resource links provided by NLM:

Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • Cognitive scores (as a change from baseline measurement), measured by ADAS-Cog (Cognitive subscale of the Alzheimer's Disease Assessment Scale) and ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living). [ Time Frame: 14 months ]

Secondary Outcome Measures:
  • Cognitive, functional and neuropsychiatric scores and overall development as measured by MMSE, NPS battery, ADCS-ADL, NPICDR-Sb, ADCS-CGIC, CSDD, C-SSRS and QoL-AD, RUD-lite. [ Time Frame: 14 months ]
  • Levels of AB1-40 and AB1-42, T-tau and P-tau in CSF [ Time Frame: 14 months ]
  • Levels of AB1-40 and AB1-42 in plasma [ Time Frame: 14 months ]
  • Evaluate the structural changes in volume of the hippocampus, posterior cingulate area, and other associated areas based on neuroimaging study with magnetic resonance imaging (MRI) variation versus baseline. [ Time Frame: 14 months ]
  • Variation in FDG-PET patterns (flurodeoxyglucose-PET) [ Time Frame: 14 months ]

Estimated Enrollment: 350
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group 1
Plasmaexchange with 20% albumin and Immune Globulin (IGIV) high dose
Biological: Albumin
Human albumin 20%
Other Names:
  • Albutein 20%
  • Human Albumin Grifols 20%
Biological: Immune globulin
Intravenous (human) immune globulin 5%
Other Names:
  • Flebogamma DIF 5%
  • flebogammadif 5%
Experimental: Treatment group 2
Plasmaexchange with 20% albumin and Immune Globulin (IGIV) low dose
Biological: Albumin
Human albumin 20%
Other Names:
  • Albutein 20%
  • Human Albumin Grifols 20%
Biological: Immune globulin
Intravenous (human) immune globulin 5%
Other Names:
  • Flebogamma DIF 5%
  • flebogammadif 5%
Experimental: Treatment group 3
Plasmaexchange with 20% albumin (low dose)
Biological: Albumin
Human albumin 20%
Other Names:
  • Albutein 20%
  • Human Albumin Grifols 20%
Biological: Immune globulin
Intravenous (human) immune globulin 5%
Other Names:
  • Flebogamma DIF 5%
  • flebogammadif 5%
No Intervention: Control (sham) group - Simulated procedure
Standard treatment with previously prescribed medications

Detailed Description:
A clinical trial comprised of 350 subjects with probable mild to moderate Alzheimer's Disease (AD) will be conducted primarily to determine whether plasmapheresis with infusion of human albumin combined with Intravenous immunoglobulin (IVIG) is able to modify patient's cognitive, functional, behavioral and global domains. There will be 3 treatment groups and one control group. The subjects will be randomized in a 1:1:1:1 proportion.

Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  1. Males or females between 55-85 years of age at the time of signing of the informed consent document.
  2. A diagnosis of Alzheimer's disease (NINCDS-ADRDA criterion), and MMSE score between >/=18 and </=26.
  3. Current stable treatment with AChEIs and/or memantine for the previous three months.
  4. The patient and a close relative or the 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).
  5. 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.
  6. A brain CAT or MRI study obtained in the 12 months prior to recruitment, showing the absence of cerebrovascular disease, should be available. Nevertheless, it is possible to use the MRI obtained during the screening period to rule out any cerebral vascular disease.
  7. A stable care taker must be available, and must attend the patient study visits.

Main Exclusion Criteria:

  1. Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters, such as for example:

    • Hypocalcemia (Ca++ < 8.7 mg/dL)
    • Thrombocytopenia (<100,000/µL)
    • Fibrinogen <1.5 g/L)
    • Prothrombin time (Quick) p<60% versus control (INR >1.5)
    • Beta-blocker treatment and bradycardia <60/min)
    • Treatment with angiotension-converting enzyme inhibitors (ACEIs) (increased risk of allergic reactions)
  2. Hemoglobin < 10 mg/dL
  3. Difficult venous access precluding plasma exchange.
  4. A history of frequent adverse reactions (serious or otherwise) to blood products.
  5. Hypersensitivity to albumin or allergies to any of the components of Albutein® 5%.
  6. History of immunoglobulin A (IgA) deficiency.
  7. Known allergies to Flebogamma® DIF components such as sorbitol.
  8. History of thromboembolic complications of intravenous immunoglobulins.
  9. Plasma creatinine > 2 mg/dl.
  10. Uncontrolled high blood pressure (systolic blood pressure of 160 mmHg or higher and/or diastolic blood pressure of 100 mmHg or higher despite treatment during the last 3 months).
  11. Liver cirrhosis or any liver problem with GPT > 2.5 x ULN, or bilirubin > 2 mg/dL.
  12. Heart diseases, as evidenced by myocardial infarction, severe or unstable angina, or heart failure (New York Association Class II, III or IV) in the past 12 months.
  13. Participation in other clinical trials, or the receiption of any other investigational drug in the three months prior to the start of the study.
  14. Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, known drug or alcohol abuse, etc.).
  15. Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.
  16. Fewer than six years of education (exclusion criteria under medical criterion).
  17. Fewer than three months with stable treatment for behavioral disorders or insomnia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01561053

Contact: Paul J. Pinciaro, PhD +1-410-814-7617

  Show 37 Study Locations
Sponsors and Collaborators
Instituto Grifols, S.A.
Grifols Biologicals Inc.
Principal Investigator: Merce Boada Rovira, MD, PhD Fundació ACE. Barcelona. Spain
Study Chair: Antonio Páez, MD Instituto Grifols, S.A.
Study Director: Laura Núñez, BSc Instituto Grifols, S.A.
  More Information

Responsible Party: Instituto Grifols, S.A. Identifier: NCT01561053     History of Changes
Other Study ID Numbers: IG1002
Study First Received: March 16, 2012
Last Updated: June 15, 2015

Keywords provided by Grifols Biologicals Inc.:
Alzheimer's disease
AB peptide
Intravenous immune globulin

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on May 22, 2017