"It was devastating," said his wife, Karin Marder. "I thought, 'Our life is over together as a couple.' But in fact it really has not been, and I have to attribute this really to the clinical trial."
In the roughly five years that her husband has taken Gammagard, there has been decline in his health, but it is minimal and the kind of slowing down you might expect from ordinary aging, she said. "He travels the subways, he does things that you and I do. And our quality of life together is what's most important," she said.
Jason Marder said he takes a creative writing class, runs errands for his wife and bikes around the city. As for his disease, "I fight it as much as I can," he said. "I feel I can handle it."
It's impossible to say how Marder would have fared without the treatment. Some patients decline rapidly, while others not for years. Hard evidence comes from large studies like the one that will conclude later this year, in which a group of patients getting the treatment is compared with a similar group given dummy infusions.
Studies on the two other drugs already have ended and results are being analyzed. The main outcome is likely to be announced by the companies as soon as it is known, and detailed results are to be presented at scientific conferences in October.
Bapineuzumab is one of the largest bets ever placed in the field of Alzheimer's disease. More than 4,000 patients are participating in four studies around the world — two in people with a gene that raises the risk of Alzheimer's and two in people who don't carry that gene.
The studies, which started enrolling patients in 2007, involve brain scans every few months. "That's enormously expensive and time-consuming," said Dr. Eric Yuen, head of clinical development for Janssen. These experiments are just now yielding results.
Concern arose when an earlier study found possible bleeding or brain abnormalities in up to 10 percent of patients on the drug. However, most had no symptoms and were able to resume treatment after a brief break, Yuen said. In fact, some researchers think these changes might be a sign the drug is working to clear the amyloid plaque.
The fact that independent monitors have not stopped the new studies has made Dr. Reisa Sperling optimistic the drug will prove to be safe. Director of the Alzheimer's center at Brigham and Women's Hospital in Boston, she has consulted for Janssen and Pfizer and enrolled patients in the studies.
Relkin, who is leading the Gammagard study, said that if all three of these drugs fail, "we're in trouble." There hasn't been a new drug even to help symptoms in nine years, he said.
Petersen of the Mayo Clinic agrees.
"If they're dead-flat negative, the impact on the field and the implication for Big Pharma could be huge," he said. Companies "may bail" from the field entirely. "They may just say, 'This nut is too tough to crack.'"
Alzheimer's info: http://www.alzheimers.gov
Alzheimer's Association: http://www.alz.org
Alzheimer's Association International Conference: http://www.alz.org/aaic/overview.asp
Marilynn Marchione can be followed at http://twitter.com/MMarchioneAP
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