Intravenous Immunoglobulin (IGIV), 10% in Alzheimer´s Disease
Intravenous Immunoglobulin (IGIV), 10% in Alzheimer´s Disease
Overall Status:
No longer recruiting
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 Age | Max Age | Gender | Healthy 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 | City | State | Zip Code | Status |
|---|---|---|---|---|
Geolocation is 0, 0 | Birmingham | Alabama | 35294 | Recruiting |
Geolocation is 0, 0 | Long Beach | California | 90806 | Recruiting |
Geolocation is 0, 0 | San Diego | California | 92103 | Recruiting |
Geolocation is 0, 0 | Santa Ana | California | 92782 | Recruiting |
Geolocation is 0, 0 | Boca Raton | Florida | 33434 | Recruiting |
Geolocation is 0, 0 | Delray Beach | Florida | 33445 | Recruiting |
Geolocation is 0, 0 | Edgewater | Florida | 32132 | Recruiting |
Geolocation is 0, 0 | Miami Lakes | Florida | 33014 | Recruiting |
Geolocation is 0, 0 | Orlando | Florida | 32806 | Recruiting |
Geolocation is 0, 0 | Decatur | Georgia | 30033 | Recruiting |
Geolocation is 0, 0 | Chicago | Illinois | 60007 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Baxter Healthcare Corporation |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Kathy Tobias, MD | Study Director | Baxter Healthcare Corporation |
Study Contact:
| Name | |
|---|---|
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
