Latest News on Alzheimer’s Drugs
The news on various Alzheimer’s drugs has been coming so fast lately that you may have had trouble keeping up.
So our primary care doctors in Delray Beach thought we’d try to help you sort out the facts.
Unfortunately, with each new drug that appears, hopes are raised only to encounter questions and objections from some quarters.
The latest drug granted fast-track approval last month by the U.S. Food and Drug Administration (FDA), is lecanemab, sold under the brand name Leqembi.
Unfortunately, it’s encountering some of the same objections as an earlier drug, aducanumab, approved in 2021. Aducanumab is marketed under the trade name Aduhelm and has since been pulled from the market by its maker, Biogen.
The New Drugs Approach
There are many forms of dementia. Alzheimer’s disease is one of them. Experts believe that between 60-80 percent of those with dementia have Alzheimer’s disease, which is characterized by memory loss and trouble planning and performing familiar tasks.
Researchers have attributed one cause to the build-up of a type of plaque in the brain called beta amyloids. This sticky compound is thought to damage communication between the cells affect memory, and eventually kill them.
Unlike other drugs on the market that are used to manage such symptoms of Alzheimer’s as anxiety and insomnia, the purpose of this new class of drugs is to treat the cause, of beta-amyloid build-up. It is not intended for use in those who are in the later stages of the disease.
If you or a loved one is experiencing mild cognitive impairment (MCT) or early-stage Alzheimer’s symptoms, you understand the urgency on the part of patients and the research community to find a cure for the disease.
This was true with Aduhelm, the first new drug since 2003 approved by the FDA to treat Alzheimer’s disease. Approved in 2021, it quickly ran into controversy, not only because of its $56,000 price tag but also because critics questioned the drug’s safety and efficacy.
They claimed the FDA submitted to pressure from Biogen and its Japanese partner, Eisai, along with desperate patients and their families, and that the clinical trial’s initial disappointing results were “reanalyzed” to show positive results in order to obtain approval.
Other critics agreed, saying the drug should have shown some cognitive improvement in actual patients, not just a reduction of beta amyloids in brain scans.
In addition, the drug resulted in serious side effects in some patients, including brain swelling and bleeding. Other common side effects noted in the trials included falls, diarrhea, headache, confusion, delirium, or disorientation.
New Hope, Similar Questions
Leqembi’s clinical trials were more robust than those of Aduhelm, showing the drug slowed the progression of Alzheimer’s by 27 percent. But they also revealed some of the same side effects as Aduhelm, including brain swelling and bleeding. In addition, three patients in the trial died, possibly from side effects that may have been linked to Leqembi.
While experts were more positive about Leqembi than Aduhelm, others remained cautious.
Neurologist Samuel Gandy, a leading Alzheimer’s physician and researcher at the Ichan School of Medicine at Mount Sinai, told Scientific American that, although patients receiving the drug declined at a slower rate than those receiving the placebo, that did not mean patients would notice the change in their everyday lives.
“By way of managing expectations, I remind patients that the benefit is a slowing of decline and that patients and families should not expect to see improvement,” he said.
“I go on to say that, because of this, neither the patient nor the family is likely to notice any effect of the drug,” he added.
Others expressed concern over the drug’s serious side effects.
“I would tell a patient, ‘In my opinion, the risks exceed the benefits, and it is not clear that it will markedly change your course,’ ” Kenneth Covinsky, a geriatrician at the University of California at San Francisco, told The Washington Post.
And although the $26,500 price tag for the drug is half of Aduhelm’s, Medicare still won’t cover it, at least initially.
Prevention is Best
The ideal solution would be to find a drug treatment that can halt the disease before symptoms start.
Gandy told Scientific American, “There’s evidence that people who have no Alzheimer’s symptoms have detectable chemical changes in their spinal fluid or blood that predict that Alzheimer’s pathology has begun. It might be possible to treat those people with drugs like lecanemab or others and have them never develop any symptoms at all.”
And the Boston Herald reported late last month that researchers at Brigham and Women’s Hospital are beginning a trial testing Leqembi in patients who are at risk of developing symptoms as they get older.
“Our goal is to see if we can change the trajectory of cognitive decline using a medication early in the disease process,” Seth Gale, a neurologist who is co-director of the Brain Health Program in the Division of Cognitive and Behavioral Neurology and lead researcher at the Brigham, told the paper.
“My hope is we find a treatment, coupled with lifestyle, that prevents the onset of Alzheimer’s disease for people who might have a higher risk,” he said.
Gandy recalled that in the 1960s and 1970s, early cancer drugs had small effects at first, but more research eventually achieved “major successes.” He foresees the same with Alzheimer’s.