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news.Baxter Healthcare has initiated a Phase III clinical trial following FDA review of its investigational new drug application to evaluate Gammagard Liquid, marketed as Kiovig in EU, for the treatment of mild-to-moderate Alzheimer's disease.
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This trial is expected to be the first of two pivotal Phase III trials required to support filing for regulatory approval for Gammagard Liquid as a potential treatment for the disease.
The Phase III trial is a prospective, 18-month, randomized, double-blind, placebo-controlled, two dose-arm, parallel study in 360 subjects of both genders, ages 50 to 89 years old, with dementia of mild-to-moderate severity. The study will determine whether Gammagard Liquid treatment results in a significantly slower rate of decline of cognitive and other functions compared to placebo. Approximately 40 US leading academic centers have been identified and will begin clinical trial enrollment within the next several weeks.
Efficacy will be assessed by two primary endpoints: Cognitive outcomes using the Alzheimer’s disease assessment scale – cognitive subscale score, and global clinical outcome as assessed by the Alzheimer’s disease cooperative study – clinical global impression of change rating.
Secondary endpoints to be assessed at 18 months include behavioral, functional and quality of life outcome measures. Other secondary endpoints will include several plasma, cerebrospinal fluid, and imaging biomarkers to assess disease progression and response to therapy.
The trial is sponsored by Baxter and partially funded by the National Institutes of Health through the Alzheimer’s disease cooperative study.