A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease

Baxalta

Status and phase: Completed; Phase 3

Conditions: Alzheimer´s Disease

Treatments: Biological: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg; Biological: Placebo solution: Human Albumin 0.25% - 4 mL/kg; Biological: Placebo solution: Human Albumin 0.25% - 2 mL/kg; Biological: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00818662

160701

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy and safety of 2 doses of Immune Globulin Intravenous (IGIV), 10% administered every 2 weeks as an intravenous (IV) infusion compared with placebo in participants with mild to moderate Alzheimer's disease (AD).

Full description

Study visits: Each participant will be tested at the investigational site, and if qualified, will be treated intravenously (through a vein) every two weeks for 70 weeks (approximately 18 months). The first three infusions must be done at the site, but if the infusions are well tolerated, subsequent infusions may be done by a qualified healthcare provider in the home or other suitable location. Each participant must return to the site every 3 months for evaluation of cognition as well as blood tests and scans of the brain.

Enrollment: 390 patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Written informed consent - participant (or participant´s legally acceptable representative) and caregiver who are willing and able to participate for the duration of the study
• Diagnosis of probable Alzheimer´s Disease (AD)
• Dementia of mild to moderate severity defined as mini-mental state examination (MMSE) 16-26 inclusive at the time of screening
• Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset consistent with AD diagnosis
• Ability to comply with testing and infusion regimen, including fluency in English or Spanish, adequate corrected visual acuity and hearing ability
• On stable doses of regulatory authority approved AD medication(s) for at least 3 months prior to screening. These medications must be continued throughout this study.
• If receiving psychoactive medications (e.g. antidepressants other than monoamine oxidase inhibitors (MAOIs) and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers, etc), must be on stable doses for at least 6 weeks prior to screening

Main Exclusion Criteria (Reasons why it might not be appropriate to participate):

• Any other forms of dementia

• Medical issues that might increase the risk of treatment with IGIV, 10%, such as:

  1. Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks
  2. Evidence of current bleeding in the brain by MRI
  3. Serious problems with the liver or kidneys
  4. Allergies to blood products

• Medical issues that might interfere with the evaluation of the treatment of dementia or might make dementia worse, such as:

  1. Diabetes
  2. Recent treatment with chemotherapy or immune suppression
  3. The recent use of other investigational drugs, especially antibody therapy for AD
  4. Severe headaches or psychiatric problems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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390 participants in 4 patient groups, including a placebo group

IGIV, 10% 400mg/kg

Experimental group

Description:

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

Treatment:

Biological: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg

IGIV, 10% 200mg/kg

Experimental group

Description:

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

Treatment:

Biological: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg

Human Albumin 0.25% Solution - 4 mL/kg

Placebo Comparator group

Description:

0.25% human albumin solution infused at 4 mL/kg/2weeks

Treatment:

Biological: Placebo solution: Human Albumin 0.25% - 4 mL/kg

Human Albumin 0.25% Solution - 2 mL/kg

Placebo Comparator group

Description:

0.25% human albumin solution infused at 2 mL/kg/2weeks

Treatment:

Biological: Placebo solution: Human Albumin 0.25% - 2 mL/kg