The Eli Lilly Trial discovers that an Alzheimer’s drug can slow the progression of the disease

Drug maker Eli Lilly announced Wednesday that a clinical trial of an experimental Alzheimer’s drug has shown it can slow the progression of the dreaded disease and allow patients to have more time when they can still live independently, perform tasks such as cooking meals, and going to the store. and drive a car.

Lilly announced its results, from a trial involving 1,736 patients, in a press release, as required by the Securities and Exchange Commission. A peer review paper will follow.

The drug, dunanimab, is not a cure, but along with two other drugs recently approved by the Food and Drug Administration, it could be a turning point in the long and frustrating quest to find a cure for Alzheimer’s disease.

“All of these point in the same direction,” said Dr. Ronald Petersen, MD, director of the Alzheimer’s Research Center at the Mayo Clinic. He added that the results for donanemab were “modest” but “meaningful”. “

Dr. Petersen has done paid consulting work for pharmaceutical companies, including Lilly’s. He was not involved in the design or implementation of any of the recent trials.

Dr. Samuel Gandhi, professor of Alzheimer’s disease research at Mount Sinai, was calmer.

“Families and researchers are stuck with what we know now, which is that two drugs have a statistical benefit but a modest clinical benefit,” he said, echoing Dr. Petersen’s assessment. He has consulted with and received research support from pharmaceutical companies but has not been involved in Lilly’s trial.

Dr. Petersen said patients and their families should be counseled about the serious side effects of dunanumab — the risk of brain swelling that can lead to death. Three patients died in Lilly’s trial.

A similar proportion of deaths followed from the same side effect in the clinical trial of Leqembi, an FDA-approved Alzheimer’s drug from Eisai. A third drug, Aduhelm, has also been approved by the Food and Drug Administration, but is rarely used due to concerns about its effectiveness and high price. Brain swelling was reported in its clinical trial and deaths were reported in patients who took Aduhelm after it was approved.

The results come after decades of failed attempts, desperation, frustration, and billions of dollars spent. Most major drug companies have simply given up on Alzheimer’s drugs.

After these failures, some researchers decided that a main hypothesis about the disease—which is led by hard Brilo-like plaques in the brain made of the amyloid protein—was incorrect. But the successes of new drugs, which attack amyloid, reinforce the hypothesis.

Taking medications is not the same as taking antibiotics and seeing a fever. To measure the new drug’s effectiveness, Lilly’s researchers instead looked at how likely patients were to progress through categories of Alzheimer’s disease, moving from mild cognitive impairment to mild dementia, or from mild to moderate dementia. These are important changes that have a profound impact on patients and their families.

The company reported that two to three out of 10 patients taking donanimab progressed over the next 18 months, compared to patients who would have expected three to four who did while on a placebo.

They also looked at how likely it was that a patient’s disease would remain completely stable over a period of time.

“One of the common things we always hear from patients who have Alzheimer’s but are very early in the disease is, ‘If I can stay at this level, I might take it,’” said Dr. Daniel Skovronsky, chief medical officer and scientist at Eli Lilly and Company.

With the new drug, 47 percent of patients remained stable over the next year compared to 29 percent who took the placebo.

In Lilly’s trial, 24 percent of patients had side effects of swelling and bleeding in the brain, and 6 percent had symptoms such as dizziness, headache, or fainting. This is twice the rate observed with Leqembi, an Eisai drug.

But Dr. Skovronsky said it’s difficult to compare data across trials because the studies had different groups of patients — Leqembi patients with less severe Alzheimer’s — and different designs. MRI scans were performed on different schedules, and the way scans were read could vary.

Deaths from brain swelling and bleeding are rare, Dr. Petersen said, but these drugs are “not for everyone.”

“They don’t make you better, but they do slow down the disease,” he said.

Dr. Petersen added that what is really needed is a drug that stops the disease before symptoms appear.

With this goal in mind, Esai and Lilly are testing their drugs in new studies in people who have large amounts of amyloid in their brains but who don’t yet have Alzheimer’s symptoms.

Defense groups have praised the statements made in Lilly’s trial.

Georg Vradenburg, chairman and co-founder of UsAgainstAlzheimer, called the donanemab results “exciting news.” Lilly, along with other companies, provides general funding to the group but not to any specific project.

“Talk to anyone with early-stage Alzheimer’s and they’ll tell you that living independently and having a higher quality of life for a longer period of time are among the most important things for them,” he said in a press release.

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