Alzheimer’s drug keeps patients stable for 3 years

It’s a small study involving only 16 patients, but any sign of progress in Alzheimer’s research is welcome in the ongoing and increasingly desperate search for a treatment.

The first report of long-term (three-year) stabilization of Alzheimer’s disease symptoms with a drug called Gammagard (Baxter) was announced today at the Alzheimer’s Association International Conference® 2012 (AAIC® 2012) in Vancouver.

The drug, which is made from natural antibodies taken from young, healthy blood donors, is an intravenous immune system treatment. Known generically as intravenous immunoglobulin (or IVIG), the therapy is typically given to people with weakened immune systems to help fight infections.

To evaluate the long-term effects of the Baxter therapy, sixteen study participants received treatment for three years, including five people who were originally given a placebo and 11 who were treated with various doses of the drug. Researchers then measured decline in the areas of cognition, memory, daily functioning and mood, according to a news release.

The findings? As a group, all of the participants who got Gammagard for the full three years had a good outcome in terms of thinking abilities, behavior and daily functioning.

Of these, the four patients who were treated with what turned out to be the most effective dose (0.4g/kg) for the full 36 months had the best outcome, showing no decline on several standard measures of cognition, memory, daily functioning and mood.

The five participants who were initially treated with a placebo experienced mental decline – but after switching to the drug, this decline slowed.

“This is the first study to report long term stabilization of Alzheimer’s symptoms with IVIG,” said study leader Norman Relkin of Weill Cornell Medical College in New York. “While the small number of participants may limit the reliability of our findings, we are very enthusiastic about the results. A Phase 3 trial is in progress and, in less than one year, we’ll have more definitive data on the efficacy of 18 months of IVIG treatment.”

Results from the larger trial will be available in less than a year, but some experts are already pointing out possible limitations to the drug’s use. These are mainly issues of cost and supply since each dose contains the pooled antibodies from the plasma of 1,000 blood donors. And the cost for each of the two treatments per month that patients need is between $1,500 and $3,000, depending on a person’s weight.

If the drug works, the challenge will be determining which of the antibodies are actually helping patients and developing a product that is easier and cheaper to make, Relkin told Reuters.

Other Alzheimer’s drugs in late stage clinic trials include Johnson & Johnson and Pfizer Inc’s bapineuzumab and Eli Lilly’s solanezumab. Unlike the Baxter therapy, these treatments use manmade antibodies to target a protein called beta amyloid, which is thought to accumulate in the brains of people with Alzheimer’s disease.

Sources: Alzheimer’s Association news release ; Reuters

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