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