IGIV-A Randomized, Double-Blind, Placebo-Controlled, Two Dose-Arm, Parallel Study of the IGIV - Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Mild-to-Moderate Alzheimer's Disease
Status: Closed to Enrollment
Start Date: Dec 17 2008
End Date: OPEN
To determine whether IGIV, 10% treatment either at a dose of 400 mg/kg body weight (BW)/2 weeks or 200 mg/ kg BW/2 weeks for 9 months results in a significantly slower rate of decline of dementia symptoms in subjects with mild-to-moderate Alzheimer’s Disease (AD) as compared to placebo, as measured by the cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog) and the Alzheimer’s Disease Cooperative Study (ADCS)-Clinical Global Impression of Change (ADCS-CGIC).
- Patients with mild-to-moderate dementia; probable Alzheimer’s disease (AD)
- Age 50-89, inclusive
- Neuroimaging consistent with AD diagnosis
- Ability to comply with testing and infusion regimen
- On stable doses of FDA-approved AD medications
- Suitable venous access
- Stable doses of psychoactive medications
Subjects will be excluded if they meet any of the following criteria:
- Possible AD
- Non-community dwelling
- Clinically significant concurrent condition (congestive heart failure; uncontrolled hypertension; malignancy; autoimmune or neuro-immunologic disorder; poorly controlled diabetes; untreated major depression; active renal disease; active migraines or frequent headaches; significantly abnormal blood chemistry/hematology; positive serology for HBsAg, Hepatitic C, HIV, IgA deficiency), or history of unstable angina, myocardial infarction, thrombosis, or head trauma within 12 months prior to screening.
- Known history of procoagulant abnormalities
- History of intracerebral hemorrhage within 5 years prior to screening
- Evidence of 2 or more microhemorrhages, major stroke, or multiple lacunae
- Uncontrolled seizure disorder
- Modified Hachinski score >4 at screen
- Known history of allergic reaction to albumin
- IgA deficiency
- Treatment with immunosuppressive drugs
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