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
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 6
- Primary Endpoint
- Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 51 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.
Arms & Interventions
IGIV, 10% at 0.4 g/kg body weight
IGIV, 10% at 0.4 g/kg body weight every 2 weeks for up to 3 years, 6 months
Intervention: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) (Drug)
IGIV, 10% at 0.2 g/kg body weight
IGIV, 10% at 0.2 g/kg body weight every 2 weeks for up to 3 years, 6 months.
Intervention: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) (Drug)
Outcomes
Primary Outcomes
Number of Infusions Causally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 6 months
Number and Severity of Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 6 months
Number of Infusions Temporally Associated With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 6 months
Number of Infusions Discontinued, Slowed or Interrupted Due to an Adverse Event (AE) or Serious Adverse Event (SAE)
Time Frame: 6 months
Secondary Outcomes
- Mini Mental State Examination (MMSE)(6 months)
- Alzheimer's Disease Cooperative Study (ADCS) - Activities of Daily Living (ADL) Inventory (ADCS-ADL/ ADCS-ADL-severe)(6 months)
- Logsdon Quality of Life in Alzheimer's Disease (QOL-AD)(6 months)
- EQ-5D Questionnaire (Proxy Version)(6 months)
- Time to Skilled Nursing Facility Placement(6 months)
- Total Score of the Cognitive Subscale of the Severe Impairment Battery (SIB)(6 months)
- Healthcare Resource Utilization Questionnaire (HRUQ)(6 months)
- Total Score of the Cognitive Subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog)(6 months)
- Neuropsychiatric Inventory (NPI) Score(6 months)
- Caregiver Burden Questionnaire(6 months)
- Volumetric MRI(6 months)