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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

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 medinfo@baxter.com

NCT01524887

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