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

Baxalta

Status and phase: Terminated; Phase 3

Conditions: Alzheimer´s Disease

Treatments: Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736579

161202

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 51+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 [e-mail] for details.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

IGIV, 10% at 0.2 g/kg body weight

Experimental group

Description:

IGIV, 10% at 0.2 g/kg body weight every 2 weeks for up to 3 years, 6 months.

Treatment:

Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

IGIV, 10% at 0.4 g/kg body weight

Experimental group

Description:

IGIV, 10% at 0.4 g/kg body weight every 2 weeks for up to 3 years, 6 months

Treatment:

Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)