Palm Beach Post Staff Writer
Monday, July 28, 2008
DELRAY BEACH — Gloria Friedman wisecracks about her Alzheimer's disease.
Asked if her memory has stopped slipping, she says, "I forget," and laughs loudly, enjoying her own joke.
Brain Matters Research Palm Beach County's high concentration of Alzheimer's victims has led Brain Matters Research to become one of the nation's top facilities for Alzheimer's clinical research. Headquarters: Delray Beach Year founded: 2002 Business: Clinical trials for new medicines Employees: 12 Phone number: (561) 374-8461
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But by now, if she hadn't been given a new drug from pharmaceutical giants Wyeth and Elan Corp., she probably wouldn't be laughing. She'd be struggling to bathe and dress herself.
Friedman, 82, of Hollywood has been taking bapineuzumab since 2006, when she entered a Phase 2 trial of the experimental treatment. The trial is being run by Brain Matters Research in Delray Beach.
With 56,000 known cases of Alzheimer's disease and an estimated 8,000 to 10,000 not yet diagnosed, Palm Beach County holds one of the largest concentrations of its victims in the country, making it a perfect location for clinical trials of experimental drugs, said Dr. Mark Brody, who runs Brain Matters with Dr. David Watson.
As a result, Brain Matters has become one of the nation's leading centers for Alzheimer's clinical research, and talks are in the works with The Scripps Research Institute in Jupiter about collaborating.
"This is kind of ground zero for Alzheimer's research," Brody said.
Brody is a long-time specialist in the research and treatment of stroke, first at the University of California at San Diego and later at Bethesda Memorial Hospital in Boynton Beach.
But Brody, 52, found treatment became formulaic - "I open the door, close the door, and that was it" - as he prescribed the same handful of drugs to patients. He wanted to move into an area where groundbreaking science could occur, and so he founded the clinic in 2002.
Watson, 39, joined Brody five years ago. His desire to help Alzheimer's victims dates back to his college days, when he took care of his grandmother as she slowly slipped into dementia. Eventually, he lost her, as well as a second grandmother and an uncle, to Alzheimer's.
"I lived this," Watson said.
Rather than seeing patients in a high-rise medical center, Brain Matters operates a modest office in a complex of one-story buildings with a mix of storefronts and professional offices. At any one time, it is conducting 10 to 12 trials of patients referred to it by the University of Miami, local hospitals and neurologists. It also finds patients by doing free Alzheimer's screening of walk-in patients.
The two men often are consulted by pharmaceutical companies about what parameters to establish for their drug trials.
"People can't stay here for seven hours of treatment and have blood work done every 30 minutes, and the drug companies would like to find that out ahead of time," Brody said.
Treatment - and scrutiny
Theirs is a unique type of medical practice. It specializes only in Alzheimer's patients and only with experimental drugs, mostly in Phase 2 and Phase 3 trials, which are conducted to determine a treatment's safety and effectiveness.
Brody and Watson must keep up with the latest in laboratory research, so they're aware of which treatments are going somewhere and which are going nowhere.
They also must maintain the minutiae of treatment over weeks and months because it will be used by their pharmaceutical sponsors to gain approval from the Food and Drug Administration to market the drug.
"There's a huge learning curve. You have to immerse yourself in FDA regulation," Brody said. "Regulatory oversight is overwhelming when you're one of the leading centers. You receive a lot of scrutiny."
For Gloria Friedman, an infusion of bapineuzumab is given every three months and she is tested in between to gauge memory loss, problem solving, attention span and her ability to perform calculations.
"I remember who this guy is and that I love him," Friedman said, turning to husband Milton.
Milton Friedman, 81, discovered his wife's condition in 2005 after a few incidents where she had forgotten things told to her only a short time before. He also is questioned between treatments by the doctors for any observations that his wife's condition has worsened.
"We've been happy with what the experiment has done but not with the Alzheimer's," Milton said. "She was a sharp lady. It's cut her desire to do things. We used to go to shows, go to New York, work on the computer, and we don't do that anymore."
The Friedmans are among 44 patients at Brain Matters who are taking part in a Phase 3 clinical trial of the Wyeth/Elan drug, which has had surprising success in victims with mild to moderate Alzheimer's.
Gloria Friedman's short-term memory losses still occur, but her longer-term memory hasn't slipped further. She remembers that she attended an all-girls high school in Boston but forgets what she had for dinner the night before.
Bapineuzumab can't cure Friedman's Alzheimer's. But it's supposed to slow the decline in memory. The results of the trial last year were successful enough for the FDA to allow Wyeth and Elan to begin an 18-month Phase 3 trial with about 2,000 patients around the country.
"It's the first time that we've seen a stabilization of the disease. Stabilization is huge. No one has beaten this disease before," Watson said.
May expand collaboration
The drug is a monoclonal antibody engineered to glom onto and remove or reduce plaque in the memory circuits of the brain that causes cells to die. Wyeth said that MRIs of patients showed those who were given the drug lost less of their brain volume than those who were given a placebo.
"Rather than taking the down escalator, we're seeing people leveling off," Brody said. "We're encouraged by the results."
While the two doctors must deal coldly with the intense scrutiny of scientific auditors from the drug companies, they also must handle their patients' fragile mental conditions.
"We have an expertise, and we mix it with our own brand of tender, loving care and hand-holding," Watson said.
Dr. Alyssa Sussman, in Boynton Beach, refers her Alzheimer's patients to Brain Matters, having worked with Brody at Bethesda for nine years. She likes having the option of sending patients in for the latest treatments. Usually, it's their only option.
"If you have a patient on one of the two FDA-approved medications, there's nothing more you can do. We think it's important for them to be on something experimental that could benefit them," Sussman said. "The medicines we have are not a cure, and what Dr. Brody is studying is at least a potential for hope."
Brain Matters is considering opening an office in Jupiter to be close to Scripps. Brody has been in talks with Scripps researcher Dr. Claes Wahlestedt about teaming up to look for biomarkers in the brain that might tip doctors off about who is susceptible to Alzheimer's so that treatment can begin much earlier.
Wahlestedt's research, published in the June edition of the journal Nature Medicine, has linked a special type of RNA to increased levels in the brain of amyloid plaque, a sticky peptide that kills nerve tissue that transmits informational impulses. By blocking that RNA type, scientists slowed the production of plaque in mice.
Eventually, Brody envisions bringing in the University of Miami with its brain bank and the Max Planck Society, which will open a bio-imaging center in Jupiter, to join Scripps and Brain Matters for joint research. Ultimately, the group could turn to pharmacogenomics - or how a person's particular genetic makeup affects his or her body's response to medication - to make for more personalized treatment of Alzheimer's patients. Drug companies are already building data gathering into clinical trials for such study.
"David and I want to be able to say we were on the front lines of finding a drug that actually changed how Alzheimer's is treated," Brody said.