The Times Herald (Norristown, PA)
Drug slows Alzheimer’s but can it make a real difference?
An experimental Alzheimer’s drug modestly slowed the brain disease’s inevitable worsening — but the anxiously awaited new data leaves unclear how much difference that might make in people’s lives.
Japanese drugmaker Eisai and its U.S. partner Biogen had announced earlier this fall that the drug lecanemab appeared to work, a badly needed bright spot after repeated disappointments in the quest for better treatments of the incurable disease.
Late Tuesday, the companies provided full results of the study of nearly 1,800 people in early stages of the mindrobbing disease. The data was presented at an Alzheimer’s meeting in San Francisco and published in The New England Journal of Medicine.
Lecanemab delayed patients’ worsening by about five months over the course of the 18-month study, Eisai’s Dr. Michael Irizarry told The Associated Press. Also, lecanemab recipients were 31% less likely to advance to the next stage of the disease during the study.
“That translates to more time in earlier stages” when people function better, Irizarry said.
Every two weeks, study participants received intravenous lecanemab or a dummy infusion. Researchers tracked them using an 18-point scale that measures cognitive and functional ability.
The study’s key finding: Those given lecanemab declined more slowly, a difference of not quite half a point on that scale over the 18 months, concluded the research team led by Dr. Christopher van
Dyck at Yale University. ings, vacations, bucket
Doctors are divided lists,” she said. over how much difference Amyloid-targeting that may make for drugs can cause side effects patients and families — that include swelling especially as the drug carries and bleeding in the some worrying potential brain, and lecanemab safety risks including did as well. One type of brain swelling. this swelling was seen in
“It is unlikely that the about 13% of recipients. small difference reported Eisai said most were mild in this trial will be noticeable or asymptomatic. by individual patients,” Also, two deaths have said Dr. Madhav been publicly reported Thambisetty of the National among lecanemab users Institute on Aging, who also were taking who noted he wasn’t blood-thinning medications speaking for the government for other health agency. problems. Eisai said Tuesday
He said many researchers the deaths can’t be attributed believe a meaningful to the Alzheimer’s improvement would require drug. at least a difference But Mayo’s Petersen of a full point on that said if lecanemab is approved 18-point scale. for use in the U.S.,
But Dr. Ron Petersen, he’d avoid prescribing it an Alzheimer’s expert at to people on blood thinners the Mayo Clinic, said the at least initially. drug’s effect was “a modest And Thambisetty said one but I think it’s the death reports raise clinically meaningful” concern about how the — because even a few drug may be tolerated months’ delay in progression outside of research studies could give someone “where patients are a little more time when likely to be sicker and they’re functioning independently. have multiple other medical conditions.”
The trial is important The Food and Drug Administration because it shows a drug is considering that attacks a sticky protein approving lecanemab called amyloid — considered under its fast-track program, one of several culprits with a decision expected behind Alzheimer’s in early January. If — can delay disease progression, approved, it would be the said Maria Carrillo, second anti-amyloid drug chief science officer on the market. for the Alzheimer’s Association. Nearly all treatments available for the 6 million
“We all understand that Americans with Alzheimer’s this is not a cure and we’re — and millions all trying to really grasp more worldwide with the what it means to slow Alzheimer’s, most common form of dementia because this is — only temporarily a first,” Carrillo said. ease symptoms. Scientists
But any delay in cognitive don’t yet know decline early on could exactly how Alzheimer’s be meaningful for “how forms but one theory much time we have with is that gunky amyloid our loved ones in a stage buildup plays a key role, of disease where we can although drug after drug still enjoy family and out-* that targets it has failed.
In a contentious move last year, the FDA approved the first amyloidtargeting drug, Biogen’s Aduhelm, despite lack of evidence of better patient outcomes. Insurers and many doctors have hesitated to prescribe the pricey drug — another reason experts have anxiously awaited word of how well the newer lecanemab may work.
If the FDA approves lecanemab, patients and their families will need a voice in deciding whether it’s worth the hassle of IV infusions and the risk of side effects for the chance of at least some delay in progression, Petersen said.
“I don’t think we’re going to stop the disease in its tracks” with just amyloid-targeting drugs, he added, saying it will take a combination of medications that target additional Alzheimer’s culprits.
Researchers are preparing to test lecanemab with other experimental drugs, and how it works in high-risk people before they show the first signs of memory problems.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.