Hope for Alzheimer's Patients as Phase III of Experimental Drug Begins

Indiana based pharmaceutical company, Eli Lilly and Co, announced the beginning of a Phase III study to test LY450139, a once-a-day oral agent for the treatment of mild to moderate Alzheimer’s disease. The trial, which has been dubbed "IDENTITY" - Interrupting Alzheimer's Dementia by Evaluating Treatment of Amyloid Pathology - will study 1,500 patients in the U.S. and 21 other countries, and will last for 21 months.

If successful, this trial could bring new hope to the 5 million elderly Americans currently suffering from Alzheimer’s disease that eventually renders its victims unable to think, remember, or care for themselves. Given the aging population and medical advances that are allowing for a longer lifespan, the number of Alzheimer’s patients is expected to at least triple by the year 2050. Currently, there is no cure for Alzheimer’s disease and the few drugs available for treatment simply help patients manage the symptoms but do not slow the underlying disease process.

"The new hope is to affect the disease at the very basic pathology, so you're actually stopping it, not just managing the symptoms," Dr. Daniel D. Christensen, professor of psychiatry, neurology and pharmacology at the University of Utah's Neuropsychiatric Institute told the Indianapolis Star.

Development of this experimental drug is based on what researchers call the “amyloid hypothesis.” The theory holds that the enzyme gamma-secretase can create a sticky protein called amyloid beta that turns into plaque on the brain and eventually kills off brain cells, leading to Alzheimer’s. Lilly’s LY450139 is designed to inhibit the enzyme that begins the reaction, thus slowing down the disease. This could preserve quality of life and independent functioning for Alzheimer’s patients in its milder stages, and potentially delay the onset of the severe stages of the disease.

Several other drug and biotech companies are also involved with clinical trials of experimental drugs for Alzheimer’s. While some are in the early stages of research, Myriad Genetics of Salt Lake City has completed its own Phase III clinical trial, involving more than 2,500 patients, of an experimental drug called Flurizan. It is being studied as a treatment for patients with a mild form of Alzheimer’s.

“It's taken the last twenty years of steady progress in understanding how this protein is deposited, how it's metabolized, all the enzymes involved," said Dr. Martin Farlow, professor of neurology at the Indiana University School of Medicine. "But we are now at a point that a number of companies have developed drugs that attack different parts of the process. Now there's a very realistic possibility of stopping this disease."