The cells in an Alzheimer’s-affected Brain are seen in this illustration provided by the National Institute on Aging/National Institutes of Health, where aberrant quantities of the beta-amyloid protein have clumped together to form brown plaques that aggregate between neurons and impair cell function. Within neurons, abnormal tau protein accumulations build up to form blue tangles that impair synaptic transmission between nerve cells. (via AP, National Institute on Aging, NIH)

In its drive to develop better treatments for dementia caused by conditions other than Alzheimer’s Disease, the scientific community thinks it has made a significant progress.

Federal officials are anticipated to evaluate and approve Lecanemab’s full approval this week. In clinical trials that lasted 18 months, the bimonthly injection has proven to be helpful in reducing the effects of Alzheimer’s disease by around six 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 neurologist from Michigan Medicine and the clinical core co-lead of the Michigan Alzheimer’s Disease Center.

“We’d love to stop the advancement or reverse the progression (of the disease), but this is the first step toward these more advantageous medicines that can actually alter how a person’s sickness develops. If we can slow it down for someone with early signs, they will have six months longer of independence in that work.

More than 6.5 million Americans suffer from Alzheimer’s disease, a degenerative brain ailment that steadily robs sufferers of their memory, cognitive abilities, and capacity for simple tasks. An exceptional degree of memory loss, especially in the short term, is the most prevalent early sign of Alzheimer’s disease.

“It’s not just a ‘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 said. “Key details, recent occurrences, or conversations are being forgotten. Maybe it happens now and then, but with time it becomes evidently persistent, progressing, and begins to affect daily activities.

Lecanemab, which is manufactured by the Japanese pharmaceutical company Eisai under the trade name Leqembi, received fast approval from the U.S. Food and Drug Administration (FDA) in January. The FDA’s advisory group then unanimously backed the advantages of the medication last month, clearing the door for the FDA to give final clearance by Thursday, July 6.

A monoclonal antibody called lecanemab acts to prevent the formation of amyloid plaque in an Alzheimer’s patient’s brain. One of two biochemical alterations that take place in a person with the disease’s brain is that plaque.

Researchers found that early-stage Alzheimer’s patients who received the medication every two weeks for 18 months shown less cognitive impairment than those who received a placebo. Brain imaging, cognitive testing, and interviews with the person’s friends and family were used to quantify decline.

According to Heidebrink, “roughly speaking, the people taking the active medication were functioning and thinking at a level the placebo group was six months earlier.” She also hypothesized that using it for more than 18 months would cause the disease to progress more slowly, however additional research is required to prove this.

Lecanemab shows promise, but there are logistical and financial obstacles that must be overcome before it can be used, which could cause a sluggish adoption.

Over the course of a year of treatment, Eisai estimates that the cost of its medication will be around $26,500 per person. That excludes the price of routine MRI or PET brain scans to check for adverse effects and verify eligibility.

Medical facilities will need to decide if they want to and are able to provide the therapy after the medicine has received full FDA approval. The extent to which insurance companies will pay for the medicine and additional tests, such as PET scans, which, according to Heidebrink, aren’t often covered but are necessary to establish eligibility, will be up to them.

Other medical issues and drugs that raise the possibility of adverse consequences like swelling or bleeding on the surface of the brain may also affect a patient’s eligibility.

Heidebrink predicted that there would be “logistical barriers to accessing the technologies that are needed to be able to decide who is appropriate for the therapy and to deliver it safely, as well as just a shortage of specialists who can say, “Yes, this person qualifies based on their symptoms and diagnostic evaluation too.”

With all of that in mind, she is confident that use of the drug will start in the late summer or early fall and grow over time. Lecanemab, according to her, has already advanced past several other medicines that were unsuccessful once they reached the clinical trial stage.

“This is the first drug where we’ve seen a clear clinical benefit rather than just a biological benefit,” the spokeswoman said.

Heidebrink expects that the latest breakthrough will spur more discoveries that bring down costs and broaden access to additional treatments. She added that additional research will be helpful for figuring out whether high-risk people could take the injections as a prophylactic approach before symptoms appear.

“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 early asymptomatic stage where the amyloid is silently building up, or are they more advanced,” she added.

“This is really a big woo,” she said. “Over the years, we’ve dealt with many pharmacological failures, but now I believe we’re making progress in both the therapeutic and diagnostic fields. Being here at this time is incredibly thrilling.

SOURCE

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