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New York Times (July 16, 2010): Drug Trials Test Bold Plan to Slow Alzheimer's
Marilyn Maldonado is not quite sure why she is at the Memory Enhancement Center in the seaside town of Oakhurst, N.J.
“What are we waiting for?” she asks. About 10 minutes later, she asks again. Then she asks again.
She is waiting to enter a new type of Alzheimer's drug study that will, in the boldest effort yet, test the leading hypothesis about how to slow or stop this terrifying brain disease.
The disease is defined by freckles of barnacle-like piles of a protein fragment, amyloid beta, in the brain. So, the current thinking goes, if you block amyloid formation or get rid of amyloid accumulations - plaque - and if you start treatment before the disease is well under way, you might have a chance to alter its course.
On Tuesday, that plan got a new push. The National Institute on Aging and the Alzheimer’s Association proposed new guidelines for diagnosis to find signs of Alzheimer’s in people who do not yet have severe symptoms, or even any symptoms at all.
The guidelines are needed for the new approach to Alzheimer’s drug development. Just about every pharmaceutical company and many biotechnology companies have experimental drugs to block amyloid - there are more than 100 in the pipeline. And the companies would like to show that if they give their drugs early, they can slow or stop the disease.
That is the ultimate goal for the drug in the study Mrs. Maldonado wants to enter, sponsored by Bristol-Myers Squibb. The company is, for the first time, testing such a drug in patients who, on evaluation with memory tests and new brain scans and tests for amyloid in cerebrospinal fluid, seem to be in a very early stage of Alzheimer’s. The idea is to attack the disease when there may still be time to stop the worst brain cell death.