A promising Alzheimer's drug is being tested at the University of Kentucky, prompting the head researcher to make a bold prediction.
"I think it is going to buy people years and years of quality of life that they wouldn't have had," said Dr. Gregory Jicha, assistant professor in the Department of Neurology at the University of Kentucky College of Medicine and Sanders-Brown Center on Aging.
Whereas previous drugs focused on curtailing the symptoms of the neurological disorder, he said, the drug being tested — Bapineuzumab — attacks what is thought to be the root cause of the disease.
One key theory about Alzheimer's is that it is caused by the build up of beta amyloid, a type of protein, in the brain. In a healthy brain, these protein fragments are broken down and eliminated. With Alzheimer's disease, the fragments accumulate to form hard, insoluble plaques. The drug, if it works as it is supposed to, would help to eliminate those plaques.
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That wouldn't necessarily reverse the damage that has been done, Jicha said, but if the medicine allows the brain to function more efficiently, it opens the door for mental rehabilitation.
"If you capture people at an early enough stage in the disease, it will allow some reversal of symptoms," he said.
He compared the recovery of an Alzheimer's patient who takes the drug to that of a stroke patient who has to relearn how to walk. The brain would not return precisely to its pre-disease state, but there would be hope that some function could be restored in time.
The trial at UK is the third phase of testing the drug. The first two rounds concentrated on making sure the drug was safe, Jicha said. This round determines its effectiveness.
The trial will involve 2,050 patients at 200 testing sites in the United States and Canada.
There is no target for the number of patients who will participate at UK, he said. In part, the number will be determined by how many patients are a good fit for the study.
The ideal candidates, he said, would be between 55 and 88 and be in the early stages of the disease. They would be provided free medicine and would be monitored for about 18 months by a medical team. Patients would be required to come in every three months for a half-day of testing and checkups.
It's important that the patient and the family agree to take part in the study, Jicha said. It can be difficult on a patient if he or she doesn't have the ability to understand exactly what is going on. But, he said, people are usually eager to help with research. And, he said, it often helps the Alz heimer's patient have a sense of accomplishment.
"Most people who engage in clinical trials are not doing it to see what the medicine can do for them," he said. They are interested in helping to combat the disease.
The creation of the drug is the culmination of years of work, Jicha said. But Alzheimer's researchers have reached a critical point. As more pieces of the puzzle are put together, he said, advancement toward a cure accelerates.
"I have a tremendous amount of hope," he said.