Baxter initiates phase III study to evaluate Gammagard Liquid for 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 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.

More information GAMMAGARD Intravenous Immunoglobulin (IGIV) in Patients with Alzheimer’s Disease

Baxter Initiates GAMMAGARD LIQUID Phase III Trial for the Treatment of Alzheimer’s Disease

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.

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Baxter claims its Gammagard immune booster protects against Alzheimer’s

Baxter International Inc.’s immune system boosting drug appeared to show some protective benefits against Alzheimer’s disease in a Baxter-funded analysis of medical claims data.

Baxter claims its Gammagard immune booster protects against Alzheimer’s

By Bruce Japsen

The Deerfield-based medical product giant is studying whether its drug, Gammagard, currently used as an intravenous immune system treatment, would slow or even stop the progression of Alzheimer’s. The medical claims analysis being used in part to justify future clinical studies, Baxter said.

The claims analysis indicated the risk of developing Alzheimer’s and related disorders may be reduced in patients previously treated with Gammagard, also known as intravenous immunoglobulin or IVIG. The study was co-authored by two executives from Plymouth Meeting, Pa.-based health data company, Surveillance Data Inc.

It analyzed medical claims data comparing 847 cases treated with Gammagard compared to 84,700 cases that were not treated. The proportion of patients diagnosed with dementia was 2 percent for treated cases compared to 4.2 percent for the untreated control group, the study showed.

The study would unlikely be used by Baxter as evidence to convince the U.S. Food and Drug Administration that Gammagard should be approved as a treatment for Alzheimer’s. Rather, researchers say the Surveillance Data study should be something used to “encourage additional research including adequate and well-controlled studies to confirm the benefits of IVIG in Alzheimer’s disease,” said Dr. Howard Fillit, professor of geriatrics, medicine and neurobiology at The Mount Sinai- NYU Medical Center in New York in a statement provided by Surveillance Data.

Controlled clinical studies are being worked on, Baxter said, but the company said the research is very early. A 24-patient study unveiled last summer by Baxter showed 16 patients on Baxter’s Gammagard had a better cognitive response than 8 patients on a placebo.

The idea behind the Baxter drug is that the body’s own immune system can potentially clear the brain of a protein fragment known as beta-amyloid that builds up and is thought to be a key in the development and progression of Alzheimer’s. Other companies, too, are studying immune system-based therapies, including a joint venture between New Jersey drug giant Wyeth and Dublin-based Elan Corp.

Alzheimer’s disease affects nearly 5 million Americans, and the number is rapidly rising. There are only some pills that slow the worsening of symptoms for about half the people who take them, experts say.

Hear Bruce Japsen on WBBM-AM 780 at 6:21 p.m. and 10:22 p.m. Mondays and 11:20 a.m. Saturdays.

bjapsen@tribune.com

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