Trials / Terminated
TerminatedNCT01524887
Phase 3 IGIV, 10% in Alzheimer´s Disease
A Phase 3 Randomized, Double-blind, Placebo-Controlled Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% Solution (IGIV, 10%) for the Treatment of Mild to Moderate Alzheimer's Disease
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 508 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 50 Years – 89 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to provide evidence of efficacy and safety to support the development of IGIV, 10% as a treatment option for patients with mild to moderate Alzheimer´s Disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Immune Globulin Intravenous (Human), 10% Solution | Intravenous infusion every 2 weeks over 18 months |
| BIOLOGICAL | Human albumin 0.25% | Intravenous infusion every 2 weeks over 18 months |
Timeline
- Start date
- 2012-01-23
- Primary completion
- 2013-07-16
- Completion
- 2013-07-16
- First posted
- 2012-02-02
- Last updated
- 2021-05-19
- Results posted
- 2015-03-31
Locations
69 sites across 8 countries: United States, Australia, Belgium, Canada, Japan, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01524887. Inclusion in this directory is not an endorsement.