CompletedPhase 3

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

United States390 participantsStarted 2008-12-19

Plain-language summary

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).

Who can participate

Age range50 Years – 89 Years

SexALL

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Exclusion criteria

✕. Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks
✕. Evidence of current bleeding in the brain by MRI
✕. Serious problems with the liver or kidneys
✕. Allergies to blood products
✕. Diabetes
✕. Recent treatment with chemotherapy or immune suppression
✕. The recent use of other investigational drugs, especially antibody therapy for AD
✕. Severe headaches or psychiatric problems

What they're measuring

Change From Baseline at 18 Months in the Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)

Timeframe: Baseline & 18 months

Change From Baseline at 18 Months in Alzheimer´s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)

Timeframe: Baseline & 18 Months

Trial details

NCT IDNCT00818662

SponsorBaxalta now part of Shire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-12-10

Results submitted2014-06-27

View on ClinicalTrials.gov More Alzheimer´s Disease trials