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Clinical Trial Details

NCT ID: NCT01561053
Date Last Changed: January 14, 2015

Overview

Research Study Summary

A clinical trial to evaluate treatments using Albumin and Immune globulin for patients with Alzheimer's Disease

Research Study 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

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.

To Learn more

Recruitment Details

Phase
2/3
Gender
Both Male and Female
Age
55 to 85 Years
Overall Status
Recruiting
Lead Sponsor
Instituto Grifols, S.A.
Duration
57 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 55 Years to 85 Years

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.

  1. Current stable treatment with AChEIs and/or memantine for the previous three months.

  2. 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).

  3. 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.

  4. 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.

  5. 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. Hypocalcemia (Ca++ < 8.7 mg/dL)

  3. Thrombocytopenia ( < 100,000/µL)

  4. Fibrinogen < 1.5 g/L)

  5. Prothrombin time (Quick) p < 60% versus control (INR > 1.5)

  6. Beta-blocker treatment and bradycardia < 60/min)

  7. Treatment with angiotension-converting enzyme inhibitors (ACEIs) (increased risk of allergic reactions)

  8. Hemoglobin < 10 mg/dL

  9. Difficult venous access precluding plasma exchange.

  10. A history of frequent adverse reactions (serious or otherwise) to blood products.

  11. Hypersensitivity to albumin or allergies to any of the components of Albutein® 5%.

  12. History of immunoglobulin A (IgA) deficiency.

  13. Known allergies to Flebogamma® DIF components such as sorbitol.

  14. History of thromboembolic complications of intravenous immunoglobulins.

  15. Plasma creatinine > 2 mg/dl.

  16. 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).

  17. Liver cirrhosis or any liver problem with GPT > 2.5 x ULN, or bilirubin > 2 mg/dL.

  18. 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.

  19. Participation in other clinical trials, or the receiption of any other investigational drug in the three months prior to the start of the study.

  20. Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, known drug or alcohol abuse, etc.).

  21. Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.

  22. Fewer than six years of education (exclusion criteria under medical criterion).

  23. Fewer than three months with stable treatment for behavioral disorders or insomnia.

Site Locations (20)

Country State City Zip Facility and Contact
United States California Sacramento 95821 Northern California Research
United States Colorado Denver 80209 Mountain View Clinical Research, Inc
United States District of Columbia Washington 20059 Howard University
United States Florida Bradenton 34205 Bradenton Research Center, Inc.
United States Florida Deerfield Beach 33064 Quantum Laboratories
United States Florida Hialeah 33016 Galiz Research, LLC
United States Florida Miami 33155 Allied Biomedical Research Institute
United States Florida Miami 33144 L&L Research Choices, Inc
United States Florida Miami 33176 Miami Dade Medical Research Institute, LLC
United States Florida Pinellas Park 33782 PharmaSeek LLC
United States Georgia Decatur 30030 iResearch Atlanta, LLC
United States New Jersey Manchester Township 08759 Mid-Atlantic Geriatric/ARC
United States New Jersey Mt. Arlington 08756 The NeuroCognitive Institute
United States Ohio Cleveland 44195 The Cleveland Clinic Foundation
United States Pennsylvania Pittsburgh 15213 University of Pittsburgh Medical Center
United States Tennessee Cordova 38018 Wesley Neurology Clinic
Spain Barcelona Hospitalet de Llobregat Hospital Universitari de Bellvitge
Spain Barcelona Terrassa Hospital Universitari Mutua de Terrassa
Spain Barcelona Funcació ACE
Spain Barcelona Hospital Vall d'Hebron

Contact

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

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