2023-07-17 17:18:05
A second Alzheimer’s drug in development may slow the disease by a few months, but it’s not without risk.
Hope for patients with Alzheimer’s? A new investigational drug seems to be slowing down slightly (from four to seven months) the inevitable aggravation of the diseaseresearchers reported on Monday.
“There is finally a hope we can talk about”said Dr John Sims, of the pharmaceutical group Eli Lilly and Company, on the sidelines of the international conference of the Alzheimer’s Association in Amsterdam.
“We do not cure the disease”he added. “There is no cure for diabetes either.but that doesn’t mean there aren’t very helpful treatments for patients.”
The Eli Lilly and Co group is seeking Food and Drug Administration approval for “donanemab”. If approved, it will be the second treatment for Alzheimer’s disease that has been convincingly shown to delay the progression of this devastating disease, after the manufacturer’s recently approved “Leqembi”. Japanese medicine Eisai.
The researchers published the full results of a study involving 1,700 patients published in the Journal of the American Medical Association (JAMA).
Donanemab and Leqembi are both laboratory-made antibodies, given intravenously, that target one of the causative agents of Alzheimer’s disease, sticky amyloid buildup in the brain.
But both of these drugs can pose a serious risk to patients: brain swelling or bleeding. In the study by Eli Lilly and Co, these risks led to the death of three patients.
Scientists say that while these drugs may mark a new era in the treatment of Alzheimer’s disease, huge questions remain about which patients should try them and how much benefit they will actually get from them.
“The modest benefits would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer. But that is not the case”wrote Dr. Eric Widera, of the University of California, San Francisco, in a JAMA editorial accompanying the results of the medical study.
The donanemab study involved on people aged 60 to 85 who were in the early stages of Alzheimer’s disease. Half of them received donanemab infusions once a month and the other half sham infusions for 18 months.
The study had a few twists and turns. Patients switched to sham infusions if enough amyloid disappeared, which happened for about half of them within a year. And like amyloid is not the only cause of Alzheimer’s disease, the researchers also tracked the levels of another culprit in the brain: abnormal tau protein. A higher amount of tau indicates a more advanced stage of the disease.
What difference does it make? This means that donanemab slowed the worsening of the disease by four to seven months, the JAMA report concludes.
Another way to measure: Among patients who received donanemab and had lower tau levels, 47% were considered stable one year into the study, compared to 29% of those who received the dummy version.
The main safety concern is swelling or bleeding in the brain, which often causes no symptoms but can sometimes be serious or even fatal. About a quarter of patients who received donanemab showed signs of swelling and about 20% presented micro-bleeds.
Scientists already know that patients receiving amyloid-targeting treatment must undergo repeated brain scans to check for these side effects, which is a costly and time-consuming hurdle.
Dr. Eric Widera noted that the possibility of stopping treatment to donanemab, at least temporarily, in people who respond well, would limit some of these challenges.
It’s too early to know if some patients might need to restart donanemab, Lilly’s Dr. Mark Mintun said. But the amyloid “isn’t coming back with some sort of vengeance,” he said, speculating it could take several years.
Another problem arises: more than 90% of study participants were white, which leaves little data on how other populations might react, Jennifer Manly, an Alzheimer’s disease expert at Columbia University, wrote in JAMA.
Scientists have long tried, unsuccessfully, to slow Alzheimer’s disease with drugs that target amyloid – and the FDA’s controversial 2021 conditional approval of a drug called Aduhelm quickly waned due to the lack of evidence of its real effectiveness.
Leqembi’s approval and promising data with donanemab have reignited interest in fighting amyloid buildup.
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