Alzheimer's Disease Education and Referral Center

Albumin and Immunoglobulin in Alzheimer's Disease

Albumin and Immunoglobulin in Alzheimer's Disease

Overall Status: 
Recruiting
Brief Description: 

This Phase II/III study will evaluate changes in cognition, functioning, and behavior in people with mild to moderate Alzheimer's disease who undergo an experimental infusion treatment with albumin and intravenous immune globulin (IVIG).

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
55 Years
85 Years
Both
No
Inclusion Criteria: 
    • Diagnosis of Alzheimer's disease (NINCDS-ADRDA criteria)
    • MMSE score of 18-26 inclusive
    • Current stable treatment with cholinesterase inhibitor or memantine for the past 3 months
    • Ability to follow study procecures, receive treatment, and continue follow-up
    • CAT or MRI scan of brain showing absence of cerebrovascular disease obtained during the past year, or MRI result used at screening
    • Caregiver who can attend all study visits
Exclusion Criteria: 
    • Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters, such as: 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), or treatment with angiotension-converting enzyme inhibitors (ACEIs) (increased risk of allergic reactions)
    • Hemoglobin <10 mg/dL
    • Difficult venous access
    • History of frequent adverse reactions (serious or otherwise) to blood products
    • Hypersensitivity to albumin or allergies to any of the components of Albutein® 5%
    • History of immunoglobulin A (IgA) deficiency
    • Known allergies to Flebogamma® DIF components such as sorbitol
    • History of thromboembolic complications of intravenous immunoglobulins
    • Plasma creatinine > 2 mg/dL
    • 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)
    • Liver cirrhosis or any liver problem with GPT >2.5 x ULN, or bilirubin >2 mg/dL
    • Heart disease, as evidenced by myocardial infarction, severe or unstable angina, or heart failure in the past year
    • Participation in other clinical trials or took investigational drug in the past 3 months
    • Any condition complicating adherence to the study protocol (for example, less than 1 year of expected survival, known drug or alcohol abuse).
    • Pregnant or nursing women or women not using effective contraceptive methods for at least 1 month after plasma exchange
    • Fewer than 6 years of education (exclusion criteria under medical criterion)
    • Less than 3 months of stable treatment for behavioral disorders or insomnia
Detailed Description: 

Three treatment groups and one control group will undergo plasmapheresis, a blood purifcation process used to treat many immune disorders. The treatment groups will receive an infusion (or a sham infusion for the control group) of one or two biological drugs: albumin, the main protein found in human blood plasma, alone or in combination with low- or high-dose intravenous immune globulin, an approved drug used to treat several immune disorders. Effects on cognition, behavior, and functioning will be assessed with standard neuropsychiatric tests.

Central Contact Information: 

For more information about this clinical trial or the study sites, please contact Paul J. Pinciaro at 410-814-7617 or paul.pinciaro@grifols.com.

Locations: 
Map Marker CityStateStatus

Geolocation is 27.4989278, -82.5748194

Site
Bradenton
Florida
Recruiting

Geolocation is 29.2858129, -81.0558894

Site
Ormond Beach
Florida
Not yet recruiting

Geolocation is 32.0835407, -81.0998342

Site
Savannah
Georgia
Not yet recruiting

Geolocation is 39.9711696, -74.3392821

Site
Manchester Township
New Jersey
Recruiting
Lead Sponsor: 
Agency
Instituto Grifols, S.A.
Collaborator Sponsor: 
Agency
Grifols Biologicals Inc.
Facility Investigators: 
NameRoleAffiliation
Merce Boada Rovira, MD, PhD
Principal Investigator
Fundació ACE. Barcelona. Spain
Antonio Páez, MD
Study Chair
Instituto Grifols, S.A.
Laura Núñez, BSc
Study Director
Instituto Grifols, S.A.
Study Contact: 
NamePhoneEmail
Paul J. Pinciaro, PhD
410-814-7617
Locations
 
 
ClinicalTrials.gov ID 
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
Study Start Date: 
March 2012
Study End Date: 
December 2016
Disease Stage: 
Early
Middle
Enrollment: 
350