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

Study:

A Randomized, Double-Blind, Placebo-Controlled, Two Dose Arm, Parallel Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease

Rationale:

n/a

Purpose:

The purpose of this study is to determine whether IGIV, 10% treatment, administered at two different doses for 18 months, slows the rate or prevents the progression of dementia symptoms in subjects with mild to moderate Alzheimer´s Disease (AD). Subjects will be randomly assigned to receive intravenous infusions of either of two doses of IGIV, 10% or placebo every two weeks for 70 weeks (36 infusions) as an add-on to conventional Food and Drug Administration (FDA)-approved AD medications.

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Alzheimer´s Disease Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Other: Placebo solution
Phase 3

Verified by Baxter Healthcare Corporation March, 2013

Sponsored by: Baxter Healthcare Corporation
Information provided by: Baxter Healthcare Corporation
ClinicalTrials.gov identifier: NCT00818662

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada 89106
United States

Norman Relkin, MD, PhD., Study Director
David Gelmont, MD., Study Director

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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