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New Alzheimer’s Drug Shows Both Modest Benefits & Side Effects

By Jake Beardslee · July 19, 2023

A new experimental Alzheimer's drug, Donanemab, shows modest cognitive benefits but poses potential safety risks.  MorgueFile¬†: see [1], CC BY-SA 3.0 , via Wikimedia Commons

A new experimental Alzheimer’s drug from Eli Lilly, called Donanemab, shows some potential to slow cognitive decline in early-stage patients but also raises troubling safety concerns, according to Dr. Eric Widera of the University of California, San Francisco.

In an interview with DW News about the latest Donanemab trial results published in JAMA, Dr. Widera said that while the drug is “a small step forward,” it is not a remedy for the degenerative disease.

“What we’re seeing with this drug is it’s not a cure. It doesn’t reverse dementia. So if you progress to the point of forgetting people, it’s not going to get that back,” Dr. Widera said.

Over 18 months, patients receiving Donanemab declined 3 points less on a 144-point cognitive scale versus those receiving a placebo. Dr. Widera questioned whether this small difference was “clinically meaningful.”

While the drug did show hopeful evidence of slowing patients’ progression to more advanced stages of Alzheimer’s, Dr. Widera cautioned that “the big concerns are that…you have to go in basically monthly” for intravenous infusions that can cause serious side effects such as brain bleeds.

Dr. Widera reported there were 3 deaths in the treatment group during the Donanemab trial, similar to another amyloid-targeting Alzheimer’s drug. He estimated Donanemab could cost around $25,000 annually, presenting major financial obstacles for many patients.

Given the safety risks and uncertainties around long-term efficacy, Dr. Widera advised doctors to carefully weigh benefits and risks when considering prescribing Donanemab. But he believes FDA approval still appears likely.

“This is not a silver bullet,” Dr. Widera said. “This is not a drug I would say absolutely yes you should get this.”

While the amyloid-targeting approach shows some promise, Dr. Widera said more research is needed to determine if it is the right strategy against Alzheimer’s or if multiple treatment approaches will be necessary.