This illustration made available by the National Institute on Aging/National Institutes of Health depicts cells in an Alzheimer’s affected brain, with abnormal levels of the beta-amyloid protein clumping together to form plaques, brown, that collect between neurons and disrupt cell function. Abnormal collections of the tau protein accumulate and form tangles, blue, within neurons, harming synaptic communication between nerve cells. (National Institute on Aging, NIH via AP)AP
The scientific community believes it has made a breakthrough in the quest for better treatments for Alzheimer’s disease and other causes of dementia.
This week, federal regulators are expected to consider -- and grant -- full approval of a drug called Lecanemab. The bi-monthly injection has shown to be effective in slowing down the effects of Alzheimer’s disease by about six months in clinical trials lasting 18 months.
“I think it’s a breakthrough saying we can target the pathology of Alzheimer’s disease and make a difference,” said Dr. Judith Heidebrink, a Michigan Medicine neurologist and clinical core co-lead of the Michigan Alzheimer’s Disease Center, who is familiar with the drug.
“We’d love to halt the progression or reverse the progression (of the disease), but this is the first kind of foot in the door to these more beneficial therapies to really change the course of someone’s disease. For someone with early symptoms, if we can slow it down, that’s six months more independence in a certain task.”
Alzheimer’s disease is an irreversible and progressive brain disorder that affects more than 6.5 million Americans by slowly destroying their memory, thinking skills, and ability to carry out simple tasks. The most common early symptom of Alzheimer’s Disease is an unusual degree of memory loss, particularly in the short term.
“It’s not just ‘Oh, what was the name of the actor in that movie I saw yesterday,’ but a ‘Did I go to a movie yesterday or not,’” Dr. Heidebrink explained. “It’s forgetting key things, recent events or conversations. Maybe it’s occasionally here and there, but clearly over time it becomes persistent, progressive, and starts to impact day-to-day activities.”
In January, the U.S. Food and Drug Administration (FDA) gave accelerated approval to lecanemab, which is produced by the Japan-based pharmaceutical company Eisai under the brand name Leqembi. Then last month, an advisory committee for the FDA unanimously endorsed the benefits of the drug, paving the way for the FDA to grant full approval by Thursday, July 6.
Lecanemab is a monoclonal antibody that works to combat the buildup of amyloid plaque in the brain of an individual with Alzheimer’s disease. That plaque is one of two biological changes that occur in the brain of a person with the disease.
During clinical trials, researchers found that participants with early symptoms of Alzheimer’s, who were given the drug every two weeks for 18 months, showed less cognitive decline than participants who were given a placebo. Decline was measured using brain imaging, cognitive testing, and interviews with people close to the person.
“Roughly speaking the folks receiving the active drug were functioning and thinking at a level the placebo group was six months earlier,” Heidebrink said. She also theorized that extending the use beyond 18 months could result in greater slowing of the disease, though more research is needed to confirm.
While lecanemab offers promise, it also comes with logistic and economic barriers to access out of the gate, which could make for a slow rollout.
Eisai expects its drug to cost about $26,500 per person over the course of a year of treatment. That doesn’t factor in the cost of regular brain scanning (via MRI or PET) to determine eligibility and then check for side effects.
Once the drug has full FDA approval, medical centers will have to determine if they want to and are able to offer the therapy. Insurance providers will have to decide to what extent they’ll cover the drug and other testing like PET scans, which Heidebrink said aren’t always covered but are necessary to determine eligibility.
Patient eligibility may also be impacted by other health conditions and medications, which can increase the risk of side effects like swelling or bleeding on the surface of the brain.
“It’ll be logistical barriers to access to the technologies that are needed to be able to decide who is appropriate for the therapy and to deliver it safely, and just a shortage of specialists who can say, ‘Yes, this person qualifies based on their symptoms and diagnostic evaluation too,” Heidebrink said.
With all of that in mind, she is optimistic about the drug’s use beginning in late summer or early fall and expanding as time goes on. She said lecanemab has already gotten further than many previous treatments tat failed once they got to the clinical trials.
“This is the first drug where we’ve seen a clear clinical benefit rather than just a biological benefit,” she said.
Heidebrink hopes the recent success will lead to more advancements that lower the price and increase access to additional therapies. She said more research will also be useful for determining if high-risk individuals could use the injections as a preventative measure before symptoms show up.
“This may be more like cancer where you have to understand what stage are people at, and their treatment is going to depend on are they in the asymptomatic stage where the amyloid is silently building up, or early symptomatic stage or are they more advanced,” she said.
“This really is a big woo,” she said. “We’ve dealt with a lot of drug failures over the years and now I think we’re making advancements in the therapeutic side and the diagnostic side. It’s really an exciting time to be in this area.”