Drug maker Eli Lilly said Wednesday that an experimental Alzheimer’s drug in a clinical trial could slow the progression of the feared disease, giving patients more time to live independently by doing tasks like cooking meals and shopping. announced that it could be increased. and driving a car.
Lilly announced the results of a trial that included 1,736 patients. news release, at the request of the Securities and Exchange Commission. A peer-reviewed paper follows.
The drug, donanemab, is not a cure, but like two other drugs recently approved by the Food and Drug Administration, it could be a tipping point in the long and frustrating quest to find a cure for Alzheimer’s disease. .
“These are all pointing in the same direction,” said Dr. Ronald Petersen, director of the Alzheimer’s Research Center at the Mayo Clinic. He added that the results for donanemab were “conservative” but “meaningful.” “
Dr. Petersen has done commissioned consulting work for pharmaceutical companies, including Lilly. He was not involved in the design or execution of recent trials.
Dr. Samuel Gandy, a professor of Alzheimer’s disease research at Mount Sinai, was more modest.
“Families and researchers are stuck with what we know today: the two drugs have statistical significance but little clinical benefit,” he said. I was consulted by a pharmaceutical company and received research support, but I was not involved in the Lilly trial.
Dr. Petersen said patients and their families should be counseled about the risk of donanemab’s devastating side effects: brain swelling, which can be fatal. In the Lilly trial he had three patients die.
A similar rate of death from the same side effects was seen in a clinical trial of Leqembi, Esai’s FDA-approved treatment for Alzheimer’s disease. A third drug, Aduhelm, has also been approved by the FDA, but is rarely used due to concerns about its efficacy and high cost. Brain swelling was reported in clinical trials, and deaths were reported in patients who took Aduhelm after approval.
The results come after decades of failed attempts, despair, despondency and billions of dollars spent.
After these failures, some researchers decided that the prevailing hypothesis that the disease was caused by hard brillo-like plaques in the brain made of amyloid protein was wrong. However, the success of new drugs that attack amyloid supports the hypothesis.
Taking medicine is not like taking antibiotics and watching the fever go away. To measure the efficacy of the new drug, Lilly researchers instead asked how far patients progressed through categories of Alzheimer’s disease, ranging from mild cognitive impairment to mild dementia, or mild to moderate dementia. These are significant changes that have a significant impact on patients and their families.
The company found that 2 to 3 out of 10 patients taking donanemab improved over the next 18 months, compared with 3 to 4 patients predicted while taking placebo. reported progress.
They also studied the possibility of a patient’s disease remaining perfectly stable for a period of time.
“One of the things we often hear from people with Alzheimer’s who are in the early stages of Alzheimer’s disease is, ‘If we stayed at this level, we could have made it through.'” Eli Lilly & at the company.
47% of patients taking the new drug remained stable the following year compared to 29% of patients taking placebo.
In Lilly’s trial, 24% of patients had side effects of brain swelling and bleeding, and 6% had symptoms such as dizziness, headaches and fainting. This is twice his rate observed with the Esai drug Leqembi.
However, according to Dr. Skovronsky, the study’s different patient populations (Leqembi patients had less severe Alzheimer’s disease) and different designs make it difficult to compare data between trials. MRI scans come on different schedules and are read in different ways.
Deaths from brain swelling and bleeding are rare, yet these drugs “are not for everyone,” Dr. Petersen said.
“They don’t make you better, but they delay the disease,” he said.
Dr. Petersen added that what we really need are drugs that stop the disease before symptoms appear.
With that goal in mind, Esai and Lilly are testing their drug in a new study of people who have large amounts of amyloid in their brains and who don’t yet have symptoms of Alzheimer’s disease.
Advocacy groups praised the data from Lilly’s trial.
George Vradenburg, chairman and co-founder of UsAgainstAlzheimer’s, called the results of donanemab “exciting news.” Lilly, along with other companies, provides general funding to the group, but not specific projects.
In a news release, he said, “When I talk to people with early Alzheimer’s disease, they say that living independently and maintaining a higher quality of life for a longer period of time is one of the most important things.” prize.
