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The Phase III trial is a prospective, 18-month, randomized, double-blind,placebo-controlled, two dose-arm, parallel study in 360 subjects of bothgenders, ages 50 to 89 years old, with dementia of mild-to-moderate severity.The study will determine whether GAMMAGARD LIQUID treatment results in asignificantly slower rate of decline of cognitive and other functions comparedto placebo. Approximately 40 U.S. leading academic centers have beenidentified and will begin clinical trial enrollment within the next severalweeks.
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Efficacy will be assessed by two primary endpoints:
-- Cognitive outcomes using the Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog), and
-- Global clinical outcome as assessed by the Alzheimer's DiseaseCooperative Study-Clinical Global Impression of Change rating (ADCS-CGIC).
Secondary endpoints to be assessed at 18 months include behavioral,functional and quality of life outcome measures. Other secondary endpointswill include several plasma, cerebrospinal fluid, and imaging biomarkers toassess disease progression and response to therapy.
The trial is sponsored by Baxter and partially funded by the NationalInstitutes of Health (NIH) through the Alzheimer's Disease Cooperative Study(ADCS). The ADCS is a cooperative agreement between the National Institute ofAging and the University of California San Diego (UCSD). The ADCS wasdeveloped in response to a perceived need to advance research in thedevelopment of therapies that might be useful for treating patients withAlzheimer's disease. The trial will be managed by Paul Aisen, M.D., directorof the Alzheimer's Disease Cooperative Study and professor, department ofNeurosciences, UCSD. The involvement of the ADCS and NIH in the conduct ofthe Phase III trial should help ensure the highest level of independentscientific evaluation of the potential role of GAMMAGARD LIQUID in thetreatment of Alzheimer's disease.
The project leader for the trial is Norman Relkin, M.D., PhD, director ofthe Memory Disorders Program and behavioral neurologist and neuroscientist atNew York-Presbyterian/Weill Cornell Medical Center, and associate professor ofclinical neurology at Weill Cornell Medical College in New York City. Dr.Relkin is also the lead investigator for the Phase I and II studies withGAMMAGARD LIQUID for the same indication.
GAMMAGARD LIQUID contains a broad spectrum of immunoglobulins(antibodies). The therapy is approved for use as an immunoglobulinreplacement therapy that boosts the immune system in patients with primaryimmunodeficiency disorders. The precise mechanisms of the therapy's effectsin Alzheimer's disease are not yet known.
To learn about enrollment patients and caregivers may go towww.clinicaltrials.gov, where details will soon be posted.
About GAMMAGARD LIQUID
GAMMAGARD LIQUID is indicated for the treatment of primaryimmunodeficiency disorders associated with defects in humoral immunity. Theseinclude, but are not limited to, congenital X-linked agammaglobulinemia,common variable immunodeficiency, Wiskott-Aldrich syndrome, and severecombined immunodeficiencies.
Important Safety Information
GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic orsevere hypersensitivity responses to Immune Globulin (
