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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 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

March 16, 2012
March 7, 2014
March 2012
December 2016   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01561053 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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 1
    Plasmapheresis with infusion of 20% albumin and Immune Globulin (IGIV) high dose
    Interventions:
    • Biological: Albumin
    • Biological: Immune globulin
  • Experimental: Treatment group 2
    Plasmapheresis with infusion of 20% albumin and Immune Globulin (IGIV) low dose
    Interventions:
    • Biological: Albumin
    • Biological: Immune globulin
  • Experimental: Treatment group 3
    Plasmapheresis with infusion of 20% albumin (low dose)
    Interventions:
    • Biological: Albumin
    • Biological: Immune globulin
  • No Intervention: Control (sham) group - Simulated procedure
    Standard treatment with previously prescribed medications
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
350
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Both
55 Years to 85 Years
No
Contact: Paul J. Pinciaro, PhD +1-410-814-7617 paul.pinciaro@grifols.com
United States,   Spain
 
NCT01561053
IG1002
No
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
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.
Grifols Biologicals Inc.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP