IVIG Use in Treatment for Alzheimer's Disease
Frequently Asked Questions
This general information on IVIG or its use for Alzheimer treatment is not intended to replace the services of a physician nor does it constitute a doctor-patient relationship. The information contained on this site is for informational and educational purposes only and should not be used as a substitute for professional medical advice. Readers should consult their own physician regarding their or their family member's care. To speak with a nurse or pharmacist about IVIG call us toll free at 866.44.BIORX (866.442.4679) or email us.
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What is Alzheimer's disease?
Alzheimer's disease is a degenerative brain process that produces, usually slowly over time, dementia or senility. It is also known as senile dementia. The brain is disrupted from the way it normally works. Mental function becomes impaired, and the patient's memory, ability to think clearly, and sometimes language are impaired. The causes of Alzheimer's are still unknown, but we do know that the disease produces physical changes in the brain. There is shrinking and widening in areas of the brain that cause connections to break and disrupts the electrical signals.
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What is IVIG?
IVIG or IntraVenous Immune Globulin therapy is the infusion of immune globulin intravenous, or into a vein. Immune globulins are antibodies found in human blood plasma. In the simplest terms, "immune globulin" and "antibody" are the same things. Antibodies are important in the body's defense against foreign substances such as viruses and other disease causing pathogens. The antibodies are collected from the pooled plasma of thousands of donors that have been carefully screened and tested for safety. IVIG manufacturers take plasma from large numbers of donors and extract the antibodies from the "pool" then concentrate, clean, and preserve the antibodies into a medically useful pharmaceutical product. IVIG is typically used for patients with autoimmune neuromuscular disorders, primary immune disorders, certain types of leukemia, and bone marrow transplants. The number of diseases treated by this group of drugs is continually growing.
There are currently several brands of IVIG. View a complete listing and their chemical characteristics.
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How is IVIG treatment given, and how often?
IVIG treatment must be prescribed by a physician. IVIG is administered, typically by a registered nurse, as an infusion into a vein (intravenous) or just under the skin (subcutaneous IVIG), a process that typically takes several hours. IVIG infusions may be administered in a variety of dosages to treat Alzheimer's. Current dosing is based on body weight and is typically given as an infusion every 2 weeks, every 4 weeks, or every month depending on physician's orders. Keep in mind that research into the dosing and frequency is in its early stages. Physicians prescribing IVIG treatment for Alzheimer's disease have used a variety of doses generally falling between 1-2 grams of IVIG per kilogram of body weight.
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How does IVIG help Alzheimer's Disease and Vascular Dementia?
Despite very promising results in several small early-stage studies, it is not fully understood to what degree IVIG therapy is effective in treating Alzheimer's disease or exactly how or why it may work as an Alzheimer’s medicine. The most widely accepted theory is that IVIG contains antibodies that may bind to beta amyloid (Aß), a central component of the plaque in the brains of Alzheimer's patients. It is believed that IVIG treatment may help promote the clearance of Aß from the brain and block Aß's toxic effects on brain cells.
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Is IVIG a new Alzheimer treatment?
IVIG treatment has been available for many years and is approved by the FDA for treating several immune disorders. It has been safely used in hundreds of thousands of patients. According to the Plasma Protein Therapeutics Association about 37,000,000 grams of IVIG have been distributed for use in the past year in the US. This means that approximately 50,000 people in the US receive IVIG treatments monthly. This number has been steadily growing as researchers continue to find beneficial uses for these drugs.
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How effective is IVIg in treating Alzheimer's?
It should be noted that IVIG use to treat Alzheimer's is in the early stages of investigation. However, as of 1/1/09 a few small clinical studies have shown very promising results. Two clinical studies have been carried out examining the effects of IVIG in Alzheimer's disease research at a mild to moderate stage of the illness. A total of 13 patients were treated in each of these two studies. While the study group was too small a number to establish conclusively whether or not the treatment works, IVIG was well-tolerated by the patients over six months of treatment. The majority showed improved cognitive ability. This has been exciting to investigators as other Alzheimer drugs on the market currently only work to temporarily halt or slow deterioration.
In 2005, researchers at the New York-Presbyterian Hospital/Weill Cornell Medical Center concluded the first clinical study that suggests that IVIG treatment may stabilize or improve cognitive function in Alzheimer patients, when administered over a period of a year or more. Learn more about this study.
A larger and more thorough Phase III Clinical Study is currently being developed. This study will involve a higher number of patients and blind studies (control groups) that incorporate placebo controls, to determine the usefulness of IVIG infusions in the treatment of Alzheimer's disease.
Obtain more information about this study and to enroll.
Currently, IVIG is not FDA approved for the treatment of Alzheimer's disease, but physicians are free to prescribe it if they believe it is warranted in a particular case. Some analysts estimate that as many as 2,000 Alzheimer's patients in the US have received IVIG treatment. You should ask your physician whether this is right for you or your family member.
View a brief video from one of the early researchers discussing the studies
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Is IVIG therapy safe and what about side effects?
IVIG therapy has been administered safely to several hundred thousand people over the years. Normally, it is well-tolerated; but as with any medication, there are risks and side effects. You should discuss these with your physician. Side effects associated with IVIG therapy tend to be few and are often related to the rate of infusion or dosage. Headache is the most common adverse reaction associated with IVIG therapy. Other common side effects may include chills, fever, muscle aches, nausea, rash, and chest tightness. The manufacturer's package insert may be reviewed for a more detailed summary of adverse reactions and contraindications. Slowing the rate of infusion can often help decrease these side effects. Pre-medication with drugs such as Benadryl and acetaminophen can also help to decrease or eliminate the discomfort of possible side effects. Being well hydrated prior to your infusion may help as well. Your physician and infusion nurse will help to advise you if pre-medications are required and administer them prior to your next infusion.
Possible severe reactions include severe headache (aseptic meningitis), stroke, and anaphylaxis (severe allergic reactions). Your healthcare provider should explain these risks and take precautions to protect or treat you in the event they occur. While very rare, severe drug reactions can occur and should be discussed if you have concerns.
Because IVIG is derived from human plasma, IVIG infusion carries with it a theoretical risk of transmission of some blood-borne pathogen, such as viruses. Advances in manufacturing processes in recent decades have included several viral-elimination technologies that have been effective at keeping the IVIG supply safe. The US blood and plasma supply is widely accepted as the safest in the world. There have been no documented cases of these diseases being transmitted by IVIG infusion in the United States in almost 25 years. There may be additional unknown risks associated with its use in an elderly population as Alzheimer's disease treatment, but many older persons have received IVIG treatment without difficulty.
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Is IVIG therapy currently available and how do you qualify for IVIG treatment for Alzheimer's?
A physician may prescribe IVIG treatment for Alzheimer's treatment if he/she feels it is warranted. A physician would evaluate the Alzheimer's patient, and, based on his/her assessment, develop a plan of treatment, which may or may not include IVIG therapy. Treatment for Alzheimer’s varies from physician to physician.
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How do you obtain IVIG treatment?
BioRx is a specialty pharmacy and infusion therapy provider which specializes in the administration of IVIG. If your physician prescribes IVIG treatment (or is interested in prescribing IVIG) you may contact BioRx at 866.44.BIORX (866.442.4679) in order to arrange care or to have BioRx give you information on cost and availability. If you are unsure or want more information, you can may us or email us at iviginfo@biorx.net and a clinician will respond to your request.
A physician must prescribe the IVIG treatment. IVIG treatments are typically administered at home, in a physician's office or at a hospital. Typically, the pharmacy will determine whether the insurance carrier will cover the medication and inform the patient of his/her financial responsibility. Then the pharmacy will make arrangements for IVIG infusions to be administered in an outpatient or home setting, based on the individual patient's needs. The pharmacy will coordinate medication, nursing and supplies for administration.
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What is the cost of IVIG treatment?
IVIG treatment costs vary widely from patient to patient. Cost is dependent upon the dose ordered (weight of the patient), the IVIG brand used, and where the patient receives it. One month of treatment typically costs between $5,000 - $10,000, which includes the expense of the IVIG itself, the infusions and other related costs. This is only an example; each patient will be different.
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Will your insurance cover IVIG treatment for Alzheimer's?
At present, IVIG is considered an off-label use for the treatment of Alzheimer's disease and is not covered by most insurance companies and may be the patient's financial responsibility. Once the Phase III Clinical Study concludes, it is possible that Medicare and other third-party payers will re-evaluate their policies regarding payment for this treatment based on the outcome of the trial; however, that is not scheduled to conclude until the end of 2010 or early to mid 2011. Therefore it is not likely that there will be any significant changes in insurance reimbursement in the near term.
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Are there any studies you can participate in to receive free treatment of Alzheimer’s?
A Phase III clinical trial for the treatment of Alzheimer's disease with IVIG is being sponsored by Baxter Healthcare Corporation. To obtain more information about this Alzeheimer’s disease research and to enroll, please go to IVIG and Alzheimer's Clinical Trials, where details are posted.
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Does BioRx recommend patients with Alzheimer's receive IVIG therapy?
Choosing to receive any medication, especially an intravenous medication such as IVIG infusions is a decision that should only be made after careful and deliberate discussion with your physician. BioRx does not make any treatment recommendations but strongly advises you to speak with your physician about new drug research regarding Alzheimer’s disease medications.
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