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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

NCT00818662 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2021-05-19

Study results available
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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).

Conditions

  • Alzheimer´s Disease

Interventions

BIOLOGICAL

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

400 mg/kg bodyweight every 2 weeks for 70 weeks

BIOLOGICAL

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

200 mg/kg bodyweight every 2 weeks for 70 weeks

BIOLOGICAL

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

Placebo solution: 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks

BIOLOGICAL

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

Placebo solution: 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks

Sponsors & Collaborators

  • Alzheimer's Disease Cooperative Study (ADCS)

    collaborator OTHER

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-19
Primary Completion
2012-12-10
Completion
2012-12-10

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00818662 on ClinicalTrials.gov