Long-Term Study of IGIV, 10% in Alzheimer´s Disease

• Status: Terminated
• Trial end date: 2013-06-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baxalta now part of Shire; Baxalta US Inc.
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

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[email protected]for details.