Trial record 3 of 6 for:    Immunoglobulin (IVIg) for Alzheimer's Disease

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 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: March 7, 2014
Last verified: March 2014
  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 2
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:


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 ] [ 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, T-tau and P-tau 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 ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine brain functional changes through FDG-PET (flurodeoxyglucose-PET) [ Time Frame: 14 months ] [ Designated as safety issue: No ]

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
Plasmapheresis with infusion of 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
Plasmapheresis with infusion of 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
Plasmapheresis with infusion of 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.

  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 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 screening, showing the absence of cerebrovascular disease, must be available. Neverthess, it is possible to use the MRI obtained during the screening 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 ClinicalTrials.gov identifier: NCT01561053

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

Locations
United States, Florida
Bradenton Research Center, Inc. Recruiting
Bradenton, Florida, United States
Neurology Associates of Ormond Beach Not yet recruiting
Ormond Beach, Florida, United States
United States, Georgia
RTR Medical Group Not yet recruiting
Savannah, Georgia, United States
United States, New Jersey
Mid-Atlantic Geriatric/ARC Recruiting
Manchester Township, New Jersey, United States
Spain
Hospital General de Elche Not yet recruiting
Elche, Alicante, Spain, 03203
Hospital de Vinalopó Not yet recruiting
Elche, Alicante, Spain, 03293
Hospital de Torrevieja Not yet recruiting
Torrevieja, Alicante, Spain, 03186
Hospital Universitari de Bellvitge Recruiting
Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Catalunya Not yet recruiting
San Cugat del Valles, Barcelona, Spain, 08190
Hospital Universitari Mutua de Terrassa Recruiting
Terrassa, Barcelona, Spain
Hospital Ntra. Sra. de la Candelaria Not yet recruiting
Santa Cruz de Tenerife, Canary Islands, Spain
Parc Hospitalari Marti i Julia Not yet recruiting
Salt, Girona, Spain
Hospital Universitario de Getafe Not yet recruiting
Getafe, Madrid, Spain, 28905
Hospital de la Santa Creu i Sant Pau Not yet recruiting
Barcelona, Spain
Funcació ACE Recruiting
Barcelona, Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain
Hospital Universitario De Burgos Not yet recruiting
Burgos, Spain, 09005
Hospital Universitari Arnau de Vilanova Not yet recruiting
Lleida, Spain, 25198
Hospital de Santa María Not yet recruiting
Lleida, Spain, 25198
Hospital General Universitario Gregorio Marañón Not yet recruiting
Madrid, Spain, 28007
Hospital Clínico San Carlos Not yet recruiting
Madrid, Spain, 28040
Hospital Universitario La Fe Not yet recruiting
Valencia, Spain, 46009
Hospital Universitario Dr. Peset Not yet recruiting
Valencia, Spain, 46017
Hospital Montecanal Not yet recruiting
Zaragoza, Spain, 50012
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: March 7, 2014
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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Antibodies
Immunoglobulins
Dementia
Tauopathies
Albunex
Contrast Media
Diagnostic Uses of Chemicals
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014