Lilly drug may slow Alzheimer's, but experts advise caution

INDIANAPOLIS -- An Alzheimer's treatment from Eli Lilly and Co. failed to slow memory decline in two separate patient studies, but the drug did show some potential to help in mild cases of the mind-robbing condition that is notoriously difficult to treat.

The Indianapolis drugmaker's announcement could be a step toward a long-awaited breakthrough in the fight against the disease. But researchers not tied to the studies -- and Eli Lilly itself -- cautioned against overreacting to the initial results.

Lilly said Friday its treatment, solanezumab, failed to slow the rate of cognitive decline, which involves a person's ability to remember things, in two late-stage studies of about 1,000 patients each. But when data from the trials were combined, scientists saw a statistically significant slowing of that rate in the bigger population.

They also saw a statistically significant result when they examined a subgroup of patients with mild cases of Alzheimer's disease. The studies focused on patients with mild to moderate Alzheimer's cases.

Lilly officials would not discuss details of the results and said they plan to talk with regulators about the next steps for the drug, which has yet to receive U.S. Food and Drug Administration approval. Full results from the studies will be presented at two scientific conferences in October. It's unclear how the FDA will view the results, given the drug missed its main goals.

William H. Thies, chief medical and scientific officer for the Alzheimer's Association, which was not involved in Lilly's research, said the statistical significance of the combined results is important.

"If that can be replicated, that is a major finding," he said. "It's the first time we've been able to change the course of Alzheimer's disease or any part of Alzheimer's disease in people."

But because the drug missed its main goals, Thies said the drug "isn't going to the (FDA) tomorrow to be approved for sale."

If you look through "rose-coloured glasses" at the results, there may be a sign of potential benefit on cognitive tests, said Dr. Ronald Petersen, director of the Mayo Clinic's Alzheimer's Disease Research Center. But it is not clear whether that is enough to make a real difference clinically in how patients do, he said.

"The danger would be an over-interpretation of a small finding or a subtle effect," said Petersen, who heads a safety monitoring panel for two companies working on a different Alzheimer's treatment.

About 35 million people worldwide have dementia, a term for brain disorders that affect memory, judgment and other mental functions. Alzheimer's is the most common type. In the United States, more than 5 million people have Alzheimer's, which is the country's sixth-leading cause of death.

Many Alzheimer's patients typically live four to eight years after diagnosis, as the disease gradually erodes their memory and ability to think or perform simple tasks. Current Alzheimer's treatments only temporarily ease symptoms such as memory loss, confusion and agitation. They don't slow, stop or reverse mental decline.

Drugmakers have tried and failed for years to develop successful treatments for the disease, and patients and doctors are anxious for something that can slow the disease's progression. Analysts have said such a treatment, if approved, could be worth billions of dollars in sales.

Earlier this month, Pfizer Inc. and Johnson & Johnson said they would end development of an intravenous version of their potential Alzheimer's treatment, bapineuzumab, after two late-stage studies showed it worked no better than a placebo in patients with mild-to-moderate cases. The companies are still studying an injectable version of the drug.

Lilly's announcement Friday comes two years after the drugmaker stopped developing another potential treatment, semagacestat, after patients taking the drug wound up faring worse than those on a placebo.

-- The Associated Press

Republished from the Winnipeg Free Press print edition August 25, 2012 B17