Families and individuals dealing with Alzheimer’s disease: Listen up.
Albany has been tapped for one of the trial sites for a study of an Alzheimer’s drug intended to slow the disease’s progression.
The Investigational Clinical Amyloid Research in Alzheimer’s study – or ICARA study – is testing the safety and efficacy of the drug bapineuzumab and is in the Phase III trial of the drug approval process. This is the final assessment of a drug before regulatory review conducted by the U.S. Food and Drug Administration.
Any progress in treatment is welcomed, as Alzheimer’s currently has no cure and is still not very well understood by scientists, but according to researchers, this treatment stands apart from others.
Current medicines for Alzheimer’s treat some symptoms, not the disease itself. Victims of Alzheimer’s suffer gradual memory loss and dwindling cognitive function, such as movement control and decision-making ability. Therefore, treatments are mostly aimed at boosting the remaining brain activity.
Lead investigator of the ICARA study, Richard Holub of Alzheimer\'s Research and Neurology Center at Neurological Associates of Albany, said the new treatment involving bapineuzumab could potentially treat the disease itself. Unlike preventative vaccination, the therapy sponsored and funded by biotechnology company Elan Pharmaceuticals would be used to treat people already diagnosed as having the disease.
“We believe this is the most significant program we’ve had, because it’s directed at the very heart of Alzheimer’s disease – the very cause,” Holub said.
Scientists believe Alzheimer’s begins with an accumulation of the protein fragment beta amyloid. The brain manufactures the protein fragment throughout life, and it only begins to accumulate in the brain after the age of 45, Holub said. At some point, depending on the genetics and lifestyle, a certain amount in a certain concentration can cause people to have memory problems – a red flag for Alzheimer’s.
“You think of it as the first domino in a cascade that leads to this disease,” Holub said. “So if we can hold that first domino in that cascade in check, maybe we can stabilize the disease.”
When this initial cause was determined, researchers including Holub and his team tried to do just that. They developed a vaccination for beta amyloid to try to eliminate it as with a virus. The vaccination research program worked to reduce the protein fragment, but the vaccination had problems of minor toxicity and with dosage response, Holub said.
“The next frame of thought was, ‘Why don’t we develop these antibodies in a laboratory?'” Holub said. “This way, there will be no question about the dose that people are getting, because you’ve made it in the lab and you know exactly how many milligrams people are getting with an intravenous infusion, so you can gauge their individual responses quite directly.”
The program went through a phase II trial where kinks were worked out and is currently in its Phase III trial, known now as the ICARA study. If Phase III proves successful, then the FDA may consider approving it as a treatment for Alzheimer’s disease that insurance companies would pay for.
The safety and efficacy of more than 600 pharmaceutical treatments for Alzheimer’s are being researched in clinical trials worldwide, according to a branch of the U.S. National Institutes of Health website.
Because Alzheimer’s is one of the most expensive diseases in the U.S. to treat – people sometimes live with it a long time and require financial support – researchers, doctors and economists alike are concerned about the ability of the U.S. to sustain the financial burden of the disease. It affects about 18 million people worldwide, with as many as 5.3 million in the U.S. alone, according to the National Institute of Neurological Disorders and Stroke website.
“The population is aging. Baby boomers are now starting to get Alzheimer’s disease,” Holub said. “It fulfills the definition of an epidemic. So there is a very significant push toward neutralizing, stabilizing, reversing and eliminating this disease as quickly as possible. There’s a sense of very significant urgency.”
To participate in the ICARA study, a volunteer must be between 50 and 88 years old and have a diagnosis of probable Alzheimer’s disease. Holub said the number of participants needed in the study is higher than usual, at about 2,000. Approximately 1,300 volunteers are enrolled in the Phase III trial across the U.S. and Canada.
Patients are treated with an intravenous infusion at the research site every three months.
Medication is provided at no cost, and throughout the 18-month study, each participant will be monitored by a medical team, including a nurse or study coordinator, and a physician. In Albany, about 20 people are participating in the study, with eight still in the screening process.
“This is real medicine and real science,” Holub said. “We know that if we can slow the progression or forestall it for even a year, or two years, it would make a huge difference to the patients, families and society – both personally and in relation to the financial burden on society and the family. We’re hoping we can do more than that, but we’ll find out.”
TIMES UNION 07/18/2009 Bethany Bump Times Union intern