Baxter initiates Ph III AD trial for Gammagard

Baxter Healthcare has initiated the first of two pivotal Phase III trials required to support filing for the regulatory approval of Gammagard liquid (intravenous immune globulin), marketed as Kiovig in the European Union, for the treatment of mild-to-moderate Alzheimer's disease.

The trial is a prospective, 18-month, randomized, double-blind, placebo-controlled, two dose-arm, parallel study in 360 subjects of both genders, aged 50 to 89 years, with dementia of mild-to-moderate severity. The trial will determine whether Gammagard 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 AD Assessment Scale-Cognitive Subscale; and global clinical outcome as assessed by the AD Cooperative Study-Clinical Global Impression of Change.

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.