The study used intravenous immunoglobulin therapy (IVIG), which is made from healthy plasma from young adults. It has been a promising treatment option for Alzheimer’s since 2004. The study was very small with only 16 patients with mild to moderate Alzheimer’s. Patients took the IVIG medication for 3 years and saw improvement in cognitive abilities and a stabilization of behavior, so symptoms did not worsen. The findings of the study were recently presented at the Alzheimer’s Association International Conference this year.
The study is very important because most patients diagnosed with Alzheimer’s experience dramatic declines in memory in only 18 months or less. The patients involved used Gammagard, a type of IVIG available from Baxter International. According to the neurologist who conducted the study, Gammagard may be a good long-term treatment option for Alzheimer’s patients with a mild to moderate form of the disease.
This study also represents the longest follow-up study ever performed on patients during a Baxter International mid-stage clinical trial. An earlier study, performed in 2007, offered promising enough results that allowed Gammagard to enter a late-stage testing for the disease. The results from this Phase III testing should be released sometime in 2013.
Many physicians who work with Alzheimer’s patients have been aware of the drug for many years and often receive questions from patients and their family. The expectation is there will be a huge demand for the drug if it gains approval. While drugs must be approved for the FDA for specific intentions, doctors are allowed to prescribe them for many purposes. Still, using a drug for off-label purposes can raise concerns about safety. With Gammagard, there is also the issue of supply.
The IVIG drug is very tough to make, and expensive. Baxter is one of many companies who produce IVIG drugs and state that it requires 130 plasma donations from healthy adults to make treatments for one patient for 12 months, when treating immunodeficiency. This also makes the findings of this study tricky, as there is a very limited supply of the drug. If the off-label demands for Alzheimer’s grows, it can threaten the supply for immunodeficiency patients who rely on this medication.
Researchers also don’t know exactly how the medication helps treat Alzheimer’s, although they believe it uses antibodies from the donor’s plasma to combat the amyloid protein, which accumulates in the brains of patients with Alzheimer’s.
Interesting notes of the drug’s effectiveness at treating Alzheimer’s comes from Dr. Devi, the director of New York Memory Services. She states that only 5% of her patients can afford the drug, because it costs over $50,000 for a single year and its use to treat the disease is not covered by insurance. She notes that one patient, who was diagnosed with Alzheimer’s 8 years before starting the drug, had difficulty speaking and walking. While taking Gammagard, the patient found huge improvement in her language and walking. Still, many of Dr. Devi’s patients experienced side effects, including a severe allergic reaction, kidney insufficiencies that reversed after the drug was discontinued and mild skin rashes.
Of course, the results from this study offer a lot of hope for Alzheimer’s patients and their family, although more studies need to be done before the drug can be approved for treatment of the disease. The study also involved only 16 patients, so it used too small a sample size and researchers knew all patients received the medication. Once the Phase III findings are released there should be a better idea about how effective this drug is at treating Alzheimer’s.