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 Alzheimer’s disease.
This clinical trial is active but not yet actively recruiting participants. This is the official name of the clinical trial, Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in PID Subjects . You can learn more about the trial including eligibility requirements and locations by following the link. We will alert you when they start actively recruiting patients.
Baxter Healthcare Corporation today announced initiation of a Phase III clinical trial following U.S. Food and Drug Administration (FDA) review of its investigational new drug application to evaluate GAMMAGARD LIQUID [Immune Globulin Intravenous (IGIV)], marketed as KIOVIG in European Union, for the treatment of mild-to-moderate Alzheimer’s disease. 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 U.S. 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 (ADAS-Cog), and
* Global clinical outcome as assessed by the Alzheimer’s Disease Cooperative 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 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 (NIH) through the Alzheimer’s Disease Cooperative Study (ADCS). The ADCS is a cooperative agreement between the National Institute of Aging and the University of California San Diego (UCSD). The ADCS was developed in response to a perceived need to advance research in the development of therapies that might be useful for treating patients with Alzheimer’s disease. The trial will be managed by Paul Aisen, M.D., director of the Alzheimer’s Disease Cooperative Study and professor, department of Neurosciences, UCSD. The involvement of the ADCS and NIH in the conduct of the Phase III trial should help ensure the highest level of independent scientific evaluation of the potential role of GAMMAGARD LIQUID in the treatment of Alzheimer’s disease.
The project leader for the trial is Norman Relkin, M.D., PhD, director of the Memory Disorders Program and behavioral neurologist and neuroscientist at New York-Presbyterian/Weill Cornell Medical Center, and associate professor of clinical neurology at Weill Cornell Medical College in New York City. Dr. Relkin is also the lead investigator for the Phase I and II studies with GAMMAGARD LIQUID for the same indication.
GAMMAGARD LIQUID contains a broad spectrum of immunoglobulins (antibodies). The therapy is approved for use as an immunoglobulin replacement therapy that boosts the immune system in patients with primary immunodeficiency disorders. The precise mechanisms of the therapy’s effects in Alzheimer’s disease are not yet known.
Original content at the Alzheimer’s Reading Room.