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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: Completed Phase 3 study, sponsored by Baxalta now part of Shire.
NCT00818662 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 390 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The ADAS-Cog is a validated psychometric instrument that evaluates memory (word recall, word recognition), attention, reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing letter in envelope) and constructional praxis (copying geometric designs). This test was administered by experienced raters certified by Alzheimer's Disease Cooperative Study (ADCS) at each site. Scores on the ADAS-Cog range from 0-70 with higher scores indicating greater imp
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 |
What the finished NCT00818662 record still lists
NCT00818662 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00818662's enrollment target sits among peer trials
390 968th of 2000 higher than 1,029 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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