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


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

++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

Name City State Zip Status Primary Contact

Birmingham Alabama

Phoenix Arizona

Long Beach California

San Diego California

Santa Ana California

Boca Raton Florida

Delray Beach Florida

Edgewater Florida

Orlando Florida

Decatur Georgia

Chicago Illinois

Springfield Illinois

Paducah Kentucky

Saint Paul Minnesota

Olive Branch Mississippi

Las Vegas Nevada

Berlin New Jersey

Chester New Jersey

Eatontown New Jersey

Summit New Jersey

Toms River New Jersey

Albany New York

Brooklyn New York

Latham New York

Manhasset New York

New Hyde Park New York

Cincinnati Ohio

Oklahoma City Oklahoma

Tulsa Oklahoma

Providence Rhode Island

Austin Texas

Dallas Texas

Houston Texas

San Antonio Texas

Bennington Vermont

Charlottesville Virginia

Milwaukee Wisconsin

Toronto Ontario

Greenfield Park Quebec

Sherbrooke Quebec

Baxter Healthcare Corporation

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

Name Phone Email
Baxter Healthcare Corp. Medical Information


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