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NCT00818662 · ClinicalTrials.gov registry record · Phase 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
A Phase 3 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 390
- Enrollment target
NCT00818662 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 390 participants.
The verdict
NCT00818662, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 390 participants
- Enrollment target
Study 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).
Interventions
- BIOLOGICAL Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg
- BIOLOGICAL Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg
- BIOLOGICAL Placebo solution: Human Albumin 0.25% - 4 mL/kg
- BIOLOGICAL Placebo solution: Human Albumin 0.25% - 2 mL/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2008-12-19 |
| Est. Completion | 2012-12-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00818662
The ClinicalTrials.gov registry entry for NCT00818662 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg is the first listed.
NCT00818662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00818662 about?
NCT00818662 is a clinical study titled "A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease". 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).
What is the current status of trial NCT00818662?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 390 participants. The study started on 2008-12-19. Estimated completion is 2012-12-10.
What interventions are being tested in trial NCT00818662?
The interventions under investigation include: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg (BIOLOGICAL), Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg (BIOLOGICAL), Placebo solution: Human Albumin 0.25% - 4 mL/kg (BIOLOGICAL), Placebo solution: Human Albumin 0.25% - 2 mL/kg (BIOLOGICAL).
Who is sponsoring clinical trial NCT00818662?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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