Is IVIg costly? IVIg is very expensive compared to medications currently in use to treat Alzheimer's disease. One month of treatment typically costs $5000-$10,000---- including the expense of the IVIg itself, the infusions and other costs.

How effective is IVIg in Alzheimer's? So far, only two clinical studies have been carried out examining the effects of IVIg in Alzheimer's disease at a mild to moderate stage of the illness. Collectively, a total of 13 patients were treated in these two studies, which is too small a number to establish whether or not the treatment works. IVIg was well-tolerated by the AD patients treated and none were noted to decline in their thinking abilities over 6 months of treatment. A majority of the patients improved on simple measures of thinking ability.

Many more persons with Alzheimer's will need to be treated in blinded studies that incorporate placebo controls before the usefulness of IVIg can be determined.

There are different "brands" of IVIg. Are they all the same? The various manufacturers of IVIg use different preparation processes, which could affect the usefulness of their product for treating Alzheimer's. The various brands of IVIg have not yet been compared in actual Alzheimer clinical trials, so it is not known whether they are all equivalent. Products made by Baxter Healthcare and Octapharm have been tested and both yielded positive effects.

How long will IVIg need to be given if it proves effective in treating Alzheimer's? It is not known how long treatment will need to be continued at this time.

Can my doctor prescribe IVIg for Alzheimer's? In theory, since IVIg is commercially available, it can be prescribed by a licensed physician. However, since the optimal dosing, preparation and patient for this treatment have yet to be determined, it is--not recommended that physicians use IVIg for this purpose at this time except in experimentally controlled clinical studies (trials). Since it is not approved to treat Alzheimer's disease, Medicare and third-party payers may choose not to pay for this treatment.

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FRIDAY, April 22 (HealthDay News) -- Regular infusions of plasma   derived antibodies appear to reduce levels of Alzheimer's disease-causing brain plaques while improving patients' thinking ability, researchers report.

Buildup of beta-amyloid protein plaques in the brain is a hallmark of Alzheimer's and toxicity related to this buildup is thought to be a major cause of the disease, for which there is currently no effective treatment.

In this phase I clinical study, conducted by a team from New York-Presbyterian Hospital/Weill Cornell Medical Center, researchers gave patients with mild to moderate Alzheimer's periodic infusions of a targeted antibody, called immunoglobulin (IVIg). The antibody makes its way to the brain where it targets beta-amyloid for removal.

The study included eight Alzheimer's patients treated with IVIg. After six months of treatment, seven of the patients underwent cognitive testing. The tests showed that cognitive function stopped declining in all seven patients and had actually improved in six of the seven patients.

"If these results are confirmed in larger, controlled trials, we might have a safe Alzheimer's treatment capable of clearing the amyloid protein away," senior researcher Dr. Marc E. Weksler said in a prepared statement.

The study was presented at the recent annual meeting of the American Academy of Neurology in Miami.

The researchers emphasize that it's too soon to describe IVIg as anything more than promising, and they do not recommend that doctors treat Alzheimer's patients with IVIg at this point in time. Preparations are already underway for a larger, controlled Phase II clinical trial of IVIg, the researchers said.

IVIg is an antibody product derived from human plasma. The U.S. Food and Drug Administration has long approved the use of IVIg to treat other conditions, but not Alzheimer's.

It has been well known that Alzheimer's causes beta amyloid deposits in the brain. Antibodies against beta amyloid can be measured in C.S.F. these antibodies are reduces in patients who go on to develop Alzheimer's.  IVIg contains these antibodies so it is no miracle that it helps stop the disease in its track.

 

The study is continued to next page-3

The other three co-authors of the Alzheimer's paper have no financial interest

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