Long-Term Study of IGIV, 10% in Alzheimer´s Disease
| Status: | Terminated |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 51 - Any |
| Updated: | 10/25/2017 |
| Start Date: | November 2012 |
| End Date: | June 2013 |
A Study of the Long-Term Safety and Efficacy of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) in Mild to Moderate Alzheimer´s Disease
The purpose of this long-term study is to provide additional evidence of safety and efficacy
of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase
3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg
or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701.
Participants and investigators will be blinded to dose unless otherwise notified by the
sponsor.
of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase
3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg
or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701.
Participants and investigators will be blinded to dose unless otherwise notified by the
sponsor.
Main Inclusion Criteria:
- Completed 18 months of study treatment and assessments in Baxter precursor study
160701
- Diagnosis of probable Alzheimer´s Disease (AD)
- Able to comply with testing and infusion regimen (including adequate corrected visual
acuity and hearing ability)
- Has a caregiver (study partner) who is willing and able to participate
Main Exclusion Criteria:
- Significant neurological disease other than AD
- Clinically significant cardiac/cardiovascular problems (e.g. uncontrolled blood
pressure, atrial fibrillation, heart disease, clotting disorders, strokes, or recent
heart attack)
- Contraindication to undergoing MRI (e.g. pacemaker [with the exception of an
MRI-compatible pacemaker], severe claustrophobia, ferromagnetic implants such as a
metal plate)
- Specific findings on brain MRI (microhemorrhages, superficial siderosis, vasogenic
edema, a 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
- 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 immunomodulatory therapies (with the exception of
immunoglobulin and non-systemic and low-dose systemic corticosteroids)
- Recent use of investigational drugs or biologics, including those aimed at altering AD
progression (with the exception of immunoglobulin)
- Active immunization for the treatment of AD at any time
There are reasons why it might not be appropriate to participate in this trial. Please
contact Medical Information at medinfo@baxter.com for details.
We found this trial at
1
site
Click here to add this to my saved trials
