The scientific community believes this research has made a breakthrough in the search for better treatments for Alzheimer’s disease and other causes of dementia.
This week, federal regulators will consider and approve full approval of a drug called lecanemab. Bimonthly injections were shown to delay the effects of Alzheimer’s disease by about six months in an 18-month clinical trial.
“I think it’s groundbreaking to be able to target the pathology of Alzheimer’s disease and make a difference,” said Michigan Medical Neurologist and Clinical Co-Chair at Michigan Alzheimer’s Center, who is familiar with the drug. Dr. Judith Heidebrink, the leader, said. .
“We want to stop or reverse the progression of[the disease]but this is the first door to more beneficial treatments that actually change the course of someone’s disease. It’s a step: for people with early symptoms, if we can slow the progression of symptoms, they can be independent for another six months on a particular task.”
Alzheimer’s disease is an irreversible, progressive brain disorder that affects more than 6.5 million Americans and slowly impairs memory, thinking, and the ability to perform simple tasks. The most common early symptom of Alzheimer’s disease is an abnormal degree of memory loss, especially in the short term.
“It’s not just ‘Oh, what was the name of that actor in that movie I saw yesterday?’ It’s ‘Did he go to the movies yesterday or didn’t he?'” explains Dr Heidebrink. bottom. “I forget important things, recent events and conversations. increase.”
In January, the US Food and Drug Administration (FDA) granted early approval to lecanemab, manufactured by Japanese pharmaceutical company Eisai under the brand name Leqembi. And last month, an FDA advisory panel unanimously approved the drug’s benefits, paving the way for the FDA to grant full approval by Thursday, July 6.
Lecanemab is a monoclonal antibody that fights amyloid plaques that build up in the brains of people with Alzheimer’s disease. This plaque is one of her two biological changes that occur in the brain of a person with this disease.
During a clinical trial, researchers found that participants with early symptoms of Alzheimer’s disease who were given the drug every two weeks for 18 months experienced less cognitive decline than those who received a placebo. discovered. Decline was measured using brain imaging, cognitive tests, and interviews with people close to the person.
“Broadly speaking, those who received active function functioned and thought at the level the placebo group did six months ago,” Heidebrink said. She also theorized that extending use beyond 18 months could further slow disease progression, but more research is needed to confirm that.
While lecanemab is promising, there are also logistical and economic barriers to immediate access that may delay deployment.
Eisai expects the drug to cost about $26,500 per person for a year of treatment. This does not take into account the cost of regular brain scans (by MRI or PET) to determine eligibility and check for side effects.
Once the drug is fully approved by the FDA, medical centers will need to determine if they want and can provide the treatment. Insurance companies will have to decide how much to cover other tests, such as medications and PET scans, but Heidebrink said these tests aren’t always covered, but determine eligibility. said it is necessary to
Patient eligibility may also be affected by other health conditions and medications, which may increase the risk of side effects such as brain surface swelling and bleeding.
“There are logistical barriers to determining who is eligible for treatment and access to the technology needed to safely deliver treatment, and ‘yes, this person is eligible based on the following criteria’. We just don’t have enough specialists to say, as well as symptoms and diagnostic assessment,” said Heidebrink.
With all that in mind, she’s optimistic about the drug’s use starting in late summer or early fall and expanding over time. She said lecanemab is already an improvement over many previous treatments that have reached clinical trials and failed.
“This is the first drug with a clear clinical benefit, not just a biological benefit,” she said.
Heidebrink hopes that recent successes will lead to further advances, lower prices and greater access to additional treatments. He said further research would also help determine whether injections could be used as a preventive measure in high-risk people before they develop symptoms.
“This could be akin to cancer. We need to understand what stage people are in, and whether the treatment is in an asymptomatic stage where amyloid is quietly building up, It depends on whether it’s in early symptomatic stages or more advanced,” she said.
“This is really welcome,” she said. “We’ve dealt with a lot of drug failures over the years, and I think we’re making progress in treatment and diagnosis now. It’s a really exciting time to be in the region.” ”
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