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

This study is currently recruiting participants.
Verified November 2012 by Grifols Biologicals Inc.
Sponsor:
Collaborator:
Grifols Biologicals Inc.
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
NCT01561053
First received: March 16, 2012
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 Human Albumin Combined With Intravenous Immunoglobulin In Patients With Mild-Moderate AD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • Cognitive scores as measured by ADAS-Cog (Cognitive subscale of the Alzheimer's Disease Assessment Scale). [ Time Frame: 14 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Levels of AB1-40 and AB1-42 in CSF [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Levels of AB1-40 and AB1-42 in plasma [ Time Frame: 14 months ] [ Designated as safety issue: No ]
  • Changes in volumetric MRI parameters [ Time Frame: 14 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group 1
Plasmapheresis with infusion of 20% albumin and 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
Plasmapheresis with infusion of 20% albumin and IGIV (intermediate 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
Plasmapheresis with infusion of 20% albumin
 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 group
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.

  Eligibility

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

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 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 screening, showing the absence of cerebrovascular disease, must be available .
  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:
  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.
  11. Liver cirrhosis or any liver problem with GPT > 2.5 x ULN, or bilirubin > 2 mg/dL.
  12. Heart diseases, including antecedents of coronary disease and heart failure.
  13. Participation in other clinical trials, or the receipt 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, toxic habits, etc.).
  15. Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561053

Contacts
Contact: Paul J. Pinciaro, PhD +1-410-814-7617 paul.pinciaro@grifols.com

Locations
Spain
Hospital Universitary Bellvitge Not yet recruiting
Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Catalunya Not yet recruiting
Sant Cugat, Barcelona, Spain
Funcació ACE Recruiting
Barcelona, Spain
Hospital Vall d'Hebron Not yet recruiting
Barcelona, Spain
Hospital Marti i Julia Not yet recruiting
Girona, Spain
Hospital Universitario Gregorio Marañón Not yet recruiting
Madrid, Spain
Sponsors and Collaborators
Instituto Grifols, S.A.
Grifols Biologicals Inc.
Investigators
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

No publications provided

Responsible Party: Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier: NCT01561053     History of Changes
Other Study ID Numbers: IG1002
Study First Received: March 16, 2012
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

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
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013