April 20, 2006

DELRAY BEACH, Fla. (Cox News Service) -- Until now, the few drugs approved to treat Alzheimer's disease have done little more than slow its progression. But a new vaccine being tested on patients at only five sites in the U.S., including one in Delray Beach, appears to show more promise.

The drug, called ACC-001, stimulates the body's immune system to attack beta-amyloid plaque -- an abnormal protein that builds up in the brain's memory circuits and is a key factor in the development of Alzheimer's disease. ACC-001 is made by Elan Pharmaceuticals of Dublin, Ireland.

"There was an immediate and noticeable improvement within a week," said Kathy, whose 81-year-old father, Ben, of Highland Beach, received the one-time vaccine last month.

Alzheimer's is a degenerative disease of the brain that is marked by a progressive loss of mental ability and function. It affects 4.5 million Americans and with an aging population, that number could reach 16 million by 2050, according to the Alzheimer's Association.

"We are sitting in the Alzheimer's capital of the world," said Dr. Mark Brody, a Delray Beach neurologist who is conducting one of the five clinical trials.

Ben, who didn't want his last name used, was diagnosed with Alzheimer's less than a year ago. Doctors prescribed Aricept and Namenda, two drugs approved by the Food and Drug Administration, but the side effects were too much -- he became anxious and aggressive.

Doctors told his family to prepare to have him go into an assisted-living facility because "there was nothing we could do about it," said Kathy, who also didn't want to be identified.

Refusing to give up, Kathy took her father to Brain Matters Research in Delray Beach, where he was retested for and diagnosed with Alzheimer's.

Brain Matters has been around for four years. It's run by Brody and David Watson, a neuropsychologist. In addition there are two other neuropsychologists, a physician assistant, five coordinators, two lab techs and three neuropsychometric evaluators. They are involved in clinical trials designed to test the safety and effectiveness of new drugs and therapies for Alzheimer's, stroke, Parkinson's disease and headache.

Brain Matters has 12 clinical trials ongoing. Its patients come from all over Florida.

The vaccine trial that Ben is in will last three years. He will be evaluated with tests that assess memory, judgment and how fast he can process information.

Before getting the vaccination in March, Ben often repeated himself, didn't know where he lived and didn't like talking on the phone.

"He was a person who lost his mental balance," Kathy said.

"He didn't know what pieces of his mind he could depend on."

But a month later, she said, things have changed.

"Now he is much more sure of himself, he doesn't repeat himself at all and you can't get him off the phone," said Kathy, who added that while her father has regained many of his social skills, he still has short-term memory problems.

Neurologist Brody said the test is designed to concentrate on safety and not necessarily effectiveness, so it's too early to tell if it's working.

"When we see improvement it could be in activity of daily living or memory tests," Brody said. "We are hoping to see improvement in both and at the very least things won't get worst and that the drug is safe."

A clinical trial of AN-1792, an earlier one-time vaccine developed by Elan, was stopped a few years ago when several participants developed encephalitis, an inflammation of the brain.

The medication was adjusted and so far there have been no problems, Watson said.

Brain Matters Research collaborates with Bethesda Memorial Hospital's Memory Program. It uses the hospital's PET scanner to help with early detection of Alzheimer's. The scanner can detect changes in the brain associated with the disease.

One in 10 people over 65 and nearly half of those over 85 suffer from Alzheimer's, and as baby boomers retire, the problem will become even worse. The global market for Alzheimer's medications generated more than $2.6 billion in 2005, according to Millennium Research Group in Toronto.

"The theory behind these medications is that they are hoping for stabilization, so when we see actual improvement, it's kind of a breakthrough," said Watson, whose research clinic also is one of 25 sites in the United States infusing patients with an antibody that is directed specifically at beta-amyloid plaque in the brain.

It's the second phase of a clinical trial that started about a year ago. Drugs usually need to go through three phases before reaching the FDA for final approval.

Kathy said she isn't worried about the risks this time around.

"With this terrible disease you know what is going to happen, so why not take the risk; what could be worse?" she said.

The FDA recently agreed to double the number of patients in the vaccine trials from 36 to 72, and Brain Matters Research expects to start enrolling more patients in the next few weeks. Qualifying patients is another matter. There is a set of exclusion and inclusion criteria that must be met, Watson said. Patients must score within a certain range in diagnostic tests that focus on such things as attention, problem solving, motor and verbal skills, memory and orientation.

Potential candidates also can't have been diagnosed with cancer in the past five years, can't be taking medications that might interact with the drug and must be 50 or older. They also must have a caregiver who is willing to accompany them to office visits.

"Basically, they are looking for moderately healthy patients with mild to moderate Alzheimer's," Watson said.