Roche, Lilly drugs set for Alzheimer's prevention trial

NEW YORK (Reuters) - Experimental Alzheimer's drugs from Roche Holding AG and Eli Lilly & Co have been selected for a high-profile clinical trial to test whether it is possible to prevent the brain-wasting disease from developing in at-risk patients.

The trial, expected to start early next year, will enroll 160 patients worldwide with inherited gene mutations that typically lead to Alzheimer's symptoms when they are as young as in their 30s, Washington University in St. Louis said on Wednesday in announcing the drugs' selection.

Drug studies over the past decade have tried and failed to slow progression of Alzheimer's among patients who already have dementia. The hope is that success in arresting symptoms in patients who are so highly predisposed to develop the disease will show the way to preventing Alzheimer's in a much wider population.

"We're going in with three different drugs, with three different mechanisms of action, to find out which works best," said Dr. Randall Bateman, a neurologist at the Washington University School of Medicine who will lead the trial.

Bateman, in a telephone interview, said about half the patients in the trial will have no symptoms at all when the study begins, while the rest will have very mild symptoms.

Dr. James Galvin, a neurologist at New York University Langone Medical Center, said such a prevention trial involving people at high genetic risk of Alzheimer's disease would require relatively few patients and could produce results within a few years.

"Each family has a genetic mutation with a defined age of onset of disease, so you can start giving the drug a certain number of years before the predicted onset," Gavin said. "If they don't get the diseease by then, you've prevented it or delayed it."

By contrast, he said a prevention trial in the general population might need to last 20 years or longer "because you wouldn't know who will get the disease or be able to predict when."

As many as 5 million people in the United States and 36 million globally are believed to have Alzheimer's, the most common form of dementia. The U.S. figure for people 65 or older may triple by 2050 as the population ages, according to the Alzheimer's Association.

The drugs chosen for the study are Roche's gantenerumab and Lilly's solanezumab. Also under consideration is a second experimental Lilly drug called a beta-secretase inhibitor, designed to reduce the beta amyloid proteins produced by the body and slow the accumulation of toxic brain plaques linked to Alzheimer's.

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Roche, Lilly drugs set for Alzheimer's prevention trial