Alzheimer's Disease Education and Referral Center

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

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

Overall Status: 
Terminated
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
89 Years
Both
No
Inclusion Criteria: 

  • 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

Exclusion Criteria: 

  • 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

Detailed Description: 

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.

Central Contact Information: 

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

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.5206608, -86.80249

Birmingham
Alabama
Name:
Phone:

Geolocation is 33.4483771, -112.0740373

Phoenix
Arizona
Name:
Phone:

Geolocation is 33.768321, -118.1956168

Long Beach
California
Name:
Phone:

Geolocation is 32.7153292, -117.1572551

San Diego
California
Name:
Phone:

Geolocation is 33.7455731, -117.8678338

Santa Ana
California
Name:
Phone:

Geolocation is 41.308274, -72.9278835

New Haven
Connecticut
Name:
Phone:

Geolocation is 26.3586885, -80.0830984

Boca Raton
Florida
Name:
Phone:

Geolocation is 26.4614625, -80.0728201

Delray Beach
Florida
Name:
Phone:

Geolocation is 28.9888754, -80.9022758

Edgewater
Florida
Name:
Phone:

Geolocation is 28.5383355, -81.3792365

Orlando
Florida
Name:
Phone:

Geolocation is 33.7748275, -84.2963123

Decatur
Georgia
Name:
Phone:

Geolocation is 41.8781136, -87.6297982

Chicago
Illinois
Name:
Phone:

Geolocation is 39.7817213, -89.6501481

Springfield
Illinois
Name:
Phone:

Geolocation is 37.0833893, -88.6000478

Paducah
Kentucky
Name:
Phone:

Geolocation is 44.9537029, -93.0899578

St. Paul
Minnesota
Name:
Phone:

Geolocation is 34.9617604, -89.8295315

Olive Branch
Mississippi
Name:
Phone:

Geolocation is 36.114646, -115.172816

Las Vegas
Nevada
Name:
Phone:

Geolocation is 39.7912261, -74.9290536

Berlin
New Jersey
Name:
Phone:

Geolocation is 40.7808333, -74.6861111

Chester
New Jersey
Name:
Phone:

Geolocation is 40.2962222, -74.0509725

Eatontown
New Jersey
Name:
Phone:

Geolocation is 40.716111, -74.3625

Summit
New Jersey
Name:
Phone:

Geolocation is 39.9537358, -74.1979458

Toms River
New Jersey
Name:
Phone:

Geolocation is 42.6525793, -73.7562317

Albany
New York
Name:
Phone:

Geolocation is 40.65, -73.95

Brooklyn
New York
Name:
Phone:

Geolocation is 42.7470225, -73.7590088

Latham
New York
Name:
Phone:

Geolocation is 40.7978787, -73.6995749

Manhasset
New York
Name:
Phone:

Geolocation is 40.7351018, -73.6879082

New Hyde Park
New York
Name:
Phone:

Geolocation is 39.1031182, -84.5120196

Cincinnati
Ohio
Name:
Phone:

Geolocation is 35.4675602, -97.5164276

Oklahoma City
Oklahoma
Name:
Phone:

Geolocation is 36.1539816, -95.992775

Tulsa
Oklahoma
Name:
Phone:

Geolocation is 41.8239891, -71.4128343

Providence
Rhode Island
Name:
Phone:

Geolocation is 30.267153, -97.7430608

Austin
Texas
Name:
Phone:

Geolocation is 32.7801399, -96.8004511

Dallas
Texas
Name:
Phone:

Geolocation is 29.7601927, -95.3693896

Houston
Texas
Name:
Phone:

Geolocation is 29.4241219, -98.4936282

San Antonio
Texas
Name:
Phone:

Geolocation is 42.878094, -73.1968001

Bennington
Vermont
Name:
Phone:

Geolocation is 38.0293059, -78.4766781

Charlottesville
Virginia
Name:
Phone:

Geolocation is 43.0389025, -87.9064736

Milwaukee
Wisconsin
Name:
Phone:

Geolocation is 43.653226, -79.3831843

Toronto
Ontario
Name:
Phone:

Geolocation is 45.485707, -73.462088

Greenfield Park
Quebec
Name:
Phone:

Geolocation is 45.4009928, -71.8824288

Sherbrooke
Quebec
Name:
Phone:
Lead Sponsor: 
Agency
Baxter Healthcare Corporation
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Kathy Tobias, MD
Study Director
Baxter Healthcare Corporation
Study Contact: 
NameEmail
Baxter Healthcare Corp. Medical Information
Locations
 
 
ClinicalTrials.gov ID 
NCT01524887 (follow link to view full record on ct.gov in new window)
Official Title: 
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
Study Start Date: 
January 2012
Study End Date: 
December 2014
Disease Stage: 
Early
Middle
Enrollment: 
402