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Hopes rise again for a drug to alter the course of Alzheimer's disease after decades of failures. Experimental therapy slowed mental decline by 30% in patients who received the highest dose in a mid-stage study, and removed much of the sticky plaque gumming their brains, manufacturers said Wednesday .
The results have been highly anticipated and have boosted the stock of the two companies involved in recent weeks.
Eisai and Biogen's drug did not achieve its primary goal in a study of 856 participants, so overall, it was considered a flop. But company officials said 161 people who received the highest dose every two weeks for 18 months did significantly better than 245 people who received fictitious treatment.
There are many warnings about work, which has been conducted by company scientists rather than academic researchers and not reviewed by external experts. The study was also too small to be definitive and the results need to be confirmed with more work, according to dementia experts. But they welcomed any glimmer of success after many failures.
"We are cautiously optimistic," said Maria Carrillo, scientific leader of the Alzheimer's Association, whose international conference in Chicago presented the results.
"A 30 percent deceleration of decline is something I would like my family member to have," and the drug's ability to erase brain plaques "seems pretty incredible," she said. said.
About 50 million people worldwide have dementia, and Alzheimer's disease is the most common type. There is no cure – current medications simply relieve symptoms. Some earlier efforts to develop a drug to slow the disease may have been attempted too late, after much damage has already occurred. The new drug was targeted earlier, in people with early Alzheimer's, and the drug works at an early stage of sticky brain plaque formation.
Study participants received one of five doses of BAN2401 or a sham treatment intravenously. After one year, companies reported that the drug did not meet the statistical objectives. But after 18 months, they saw an advantage in the highest dose group.
What makes it difficult, however, is that they used a new way of measuring mental decline, a scale that combines parts of three other widely used tests. This is the first study to use this measurement, and it is unclear what difference makes a 30% deceleration of decline – if it allows someone to continue to bathe or feed themselves, for example . "It 's intriguing, but these are models that we' ve not used to seeing," and it will take more study for doctors to feel at home. comfortable with this measure of success, said an independent expert, Dr. Julie Schneider of Rush University Medical Center of Chicago.
According to a traditional measure of reasoning capacity, the highest doses were 47% lower than those who received a fictitious treatment.
Brain scans have added evidence that the drug might be effective. All participants had signs of sticky plaques that are the hallmark of Alzheimer's disease early in the study, but 81% of people receiving the highest dose saw all signs disappearing after 18 months , said an Eisai official.
Side effects leading to discontinuation of treatment occurred in 19 percent of those on the high dose and 6 percent of the fictitious treatment group. Cases of swelling of the brain, which have been observed in other treatments targeting the plaques in the brain, occurred in two people in the placebo group and in 16 people in the high dose group.
Other dementia experts were encouraged.
"It's a very promising result, it means we're perhaps on the right track," said another scientist without a role in the work, Dr. Stephen Salloway, head of neurology at Brown University in Providence, Rhode Island.
Dr. Reisa Sperling, a neurologist at Brigham and Women's Boston Hospital, Harvard affiliate, said it's important to realize that this is not a cure, but may be a slowing down of the decline .
"We do not suddenly bring people back to their pre-Alzheimer reference level," she said.
Dr. Lynn Kramer, chief medical officer of the Eisai Neurology Unit, said companies would discuss with regulators new studies.
The shares of Biogen, based in Cambridge, Mbadachusetts, and Eisai, based in Tokyo, climbed after July 5 when they announced that the drug had slowed the progression of early Alzheimer's disease for some patients. Biogen's stock jumped 19.6% in one day, its biggest move in 14 years, and continued to grow. Eisai exploded 40% in two days.
Biogen's stock gyrated in trading after the market after the results of the study were released. After changing gains and losses several times, it dropped by 6.5%.
Marley Jay, editor of the AP Markets, contributed to this report from New York.
Marilynn Marchione can be followed on Twitter at the following address: http://twitter.com/MMarchioneAP
The Department of Health and Science of the Associated Press receives the support of the Department Scientific Education Howard Hughes Medical Institute. The AP is solely responsible for all content.
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