The drug, donanemab, has been shown to slow progression of memory and thinking problems by about a third, but that rate doubles to 60 percent if the drug is started when patients are only mildly impaired, according to new trial data presented by Eli Lilly on Monday at the Alzheimer’s Association International Conference in Amsterdam.
The full analysis presented by the American pharmaceutical company showed results were less robust for older, later-stage patients as well as those with higher levels of a protein called tau, which has been linked to Alzheimer’s disease progression.
The findings underscored that “earlier detection and diagnosis can really change the trajectory of this disease”, Anne White, president of neuroscience at Eli Lilly, told the Reuters news agency.
The drug consists of injecting donanemab, an intravenous antibody designed to remove deposits of a protein called beta amyloid from the brains of Alzheimer’s patients.
Donanemab’s treatment effect continued to increase relative to placebos over the course of the 18-month trial, even for participants who had been taken off the drug after their levels of amyloid deposits fell significantly.
“At the end of the trial, the average patient had been without the drug for seven months, and yet they continued to benefit,” White said.
The company expected the US Food and Drug Administration to decide by the end of this year whether to approve donanemab. It said submissions to other global regulators were under way and most will be completed by year’s end.
More than 55 million people worldwide are affected by dementia, and the number is projected to rise to 139 million people by 2050, according to Alzheimer’s Disease International, the worldwide federation of Alzheimer’s associations.
The new medication has been welcomed with enthusiasm by patients. Joe Montminy, who was diagnosed with early onset Alzheimer’s disease at 54, said the disease has kept “changing the core of who I am” over the past six years.
“Everyday things like projects around the house or something as simple as texting now take me two to three times longer than they did just six months ago,” Montminy told Al Jazeera.
His wife and mother noticed changes in his personality, including mood swings, impulsiveness and a short temper, which he says are “out of character”.
“I’m very excited about having these new treatments because getting six months, nine months or more quality time with my wife, my sons and my friends would be priceless,” Montminy said.
Side effects
Al Jazeera’s Step Vaessen, reporting from Amsterdam, said the findings have been hailed as a “breakthrough” at the conference but “real division” remains within the scientific community.
The full analysis also highlighted side effects including brain swelling. Brain bleeding occurred in 31 percent of the donanemab group and about 14 percent of the placebo group.
The deaths of three trial patients were linked to the treatment, researchers reported.
“Scientists I spoke to who are not here at the conference say that [the drug] is too driven by the pharmaceutical industry,” she said. “Big pharma is pushing for a new medicine because it’s a huge group of patients they are targeting.”
An additional downside was the cost of the medication. “It is estimated that it’s going to cost around $26,000 per patient per year,” Vaessen said.
More than 6 million Americans are living with Alzheimer’s, and that number is projected to rise to nearly 13 million by 2050, according to the Alzheimer’s Association.
Another recently approved drug, Leqembi from Japanese drugmaker Eisai, also comes with serious safety concerns, including brain swelling and bleeding.
Scientists said that while these drugs may mark a new era in Alzheimer’s therapy, huge questions remain about which patients should try them and how much benefit they will really notice.