WASHINGTON (AP) — Eli Lilly & Co. reported Wednesday that an experimental medication might slow mild Alzheimer’s if people take it early enough, one of a handful of drugs in late-stage testing in the frustrating hunt for a better treatment.
The new findings don’t prove that Lilly’s solanezumab really works; a larger study is underway that won’t end until late 2016. On Wednesday, researchers at the Alzheimer’s Association International Conference updated ongoing research into Lilly’s effort, and those of two competitors, that aim to fight Alzheimer’s with injections targeting a sticky protein that clogs the brain.
The bottom line: It’s going to take more time to figure out if this approach works, but scientists think it’s still the right target despite high-profile failures in recent years.
“These are not definitive reports that are going to lead to medications being approved tomorrow. What they represent is an important foundation for us moving forward,” said Dr. David Knopman of the Mayo Clinic, who has monitored some of Lilly’s data.
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Today’s Alzheimer’s drugs only temporarily ease symptoms. Scientists caution that better care likely will require combinations of drugs that work in different ways, not just targeting amyloid. The National Institutes of Health expects to spend $586 million on Alzheimer’s research this year; different spending bills pending in Congress potentially could add up to another $350 million.
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In previous studies, solanezumab failed to help Alzheimer’s patients overall. But there was a signal that the drug might help people with very mild disease, apparently slowing their mental decline by about a third. Lilly continued to track that subset of 1,300 milder patients, giving everyone the drug for another two years, including patients who had initially received a placebo.
The group that took solanezumab from the beginning fared better than the group that started later, although the difference was small — about two points on cognitive test scores, Lilly researchers reported. They couldn’t say what that might mean for daily functioning.
“Our hope is that slowing will be increasingly noticeable over time,” said lead researcher Dr. Paul Aisen of the University of Southern California.
Roche stopped one late-stage study of gantenerumab last December because it didn’t meet its main goal of a cognitive benefit in people with early Alzheimer’s symptoms. Wednesday, researchers said a closer analysis found some patients did show signs of less amyloid in their brains, and another Alzheimer’s-related protein named tau improved, too.
Probably, the gantenerumab doses were too low, concluded lead researcher Dr. Philip Scheltens of the VU University Medical Center in Amsterdam.
Gantenerumab is being tested in two additional large studies, and doses used in them will be raised, said Roche’s Dr. Robert Lasser.
Biogen released results of its small, first-stage study of aducanumab last spring, showing that it appeared to slow cognitive decline in some patients. On Wednesday, it provided additional details confirming a higher dose worked better. One side effect, brain inflammation in some people, tended to clear in several weeks and was “both monitorable and manageable,” said Biogen clinical director Jeff Sevigny.
A large late-stage study is beginning.