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Intravenous Immunoglobulin (IGIV), 10% in Alzheimer´s Disease

  • Terminated

The purpose of this study is to test the efficacy and safety of intravenous immunoglobulin (IGIV), 10%, as a treatment for people with mild to moderate Alzheimer´s disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 89 Years Both No
January 2012
December 2014
402

++Diagnosis of probable mild to moderate Alzheimer´s disease, defined as Mini-Mental State Examination score of 16-26++Neuroimaging performed after symptom onset consistent with Alzheimer's disease diagnosis++Taking stable doses of Alzheimer's medication(s) for at least 12 weeks prior to screening++If taking psychoactive medications (e.g., antidepressants other than monoamine oxidase inhibitors and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers), must be on stable dose for at least 6 weeks prior to screening

++Non-Alzheimer's dementia++Current residence in a skilled nursing facility++Contraindication to MRI (e.g., pacemaker, severe claustrophobia, magnetic implants)++Clinically significant cardiovascular problems (e.g., uncontrolled blood pressure, heart disease, clotting disorders, strokes, or recent heart attack)++Brain MRI findings of microhemorrhages, superficial siderosis, macrohemorrhage, major stroke, or multiple lacunae++Active malignancy or history of malignancy within 5 years prior to screening, with the exception of the following: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment++Active autoimmune or neuro-immunologic disorder++Uncontrolled major depression, psychosis, or other major psychiatric disorder(s)++Poorly controlled diabetes, serious problems with liver or kidneys++Known history of hypersensitivity following infusions of human blood or blood components (e.g. human immunoglobulins or human albumin); current or recent treatment with immunoglobulin and/or immunomodulatory therapies; recent use of investigational drugs or biologics, including those aimed at altering Alzheimer's progression; active immunization for the treatment of Alzheimer's at any time

IVIG is a drug used to treat immune disorders. In Alzheimer's disease research, it is being investigated as an immunotherapy. In this Phase III trial, it will be given as an intravenous infusion every 2 weeks for 18 months.

For more information about this clinical trial, please contact Baxter Healthcare Corp. Medical Information at medinfo@baxter.com.

Name City State Zip Status Primary Contact
Site Birmingham Alabama

Site Phoenix Arizona

Site Long Beach California

Site San Diego California

Site Santa Ana California

Site Boca Raton Florida

Site Delray Beach Florida

Site Edgewater Florida

Site Orlando Florida

Site Decatur Georgia

Site Chicago Illinois

Site Springfield Illinois

Site Paducah Kentucky

Site St. Paul Minnesota

Site Olive Branch Mississippi

Site Las Vegas Nevada

Site Berlin New Jersey

Site Chester New Jersey

Site Eatontown New Jersey

Site Summit New Jersey

Site Toms River New Jersey

Site Albany New York

Site Brooklyn New York

Site Latham New York

Site Manhasset New York

Site New Hyde Park New York

Site Cincinnati Ohio

Site Oklahoma City Oklahoma

Site Tulsa Oklahoma

Site Providence Rhode Island

Site Austin Texas

Site Dallas Texas

Site Houston Texas

Site San Antonio Texas

Site Bennington Vermont

Site Charlottesville Virginia

Site Milwaukee Wisconsin

Site Toronto Ontario

Site Greenfield Park Quebec

Site Sherbrooke Quebec

Baxter Healthcare Corporation

Name Role Affiliation
Kathy Tobias, MD Study Director Baxter Healthcare Corporation

Name Phone Extension Email
Baxter Healthcare Corp. Medical Information medinfo@baxter.com

A Phase 3 Randomized, Double-blind, Placebo-Controlled Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) for the Treatment of Mild to Moderate Alzheimer`s Disease