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FDA-Approved Treatment Sheds New Hope on Treating Alzheimer’s Disease

There are multiple medications that can slow Alzheimer’s disease or treat symptoms, including recently approved Kisunla

By Angela Myers

According to the U.S. Centers for Disease Control and Prevention, an estimated 6.7 million Americans are impacted by Alzheimer's disease, and it's one of the top 10 leading causes of death in the United States. While there isn't a "cure," the FDA has approved a few medications to slow the disease's progression or to help manage symptoms. The most recent addition to that list is Kisunla.

Kisunla is an infusion designed to help patients with mild Alzheimer's. To better understand this drug, other available Alzheimer's treatments and what interventions are on the horizon, we talked to two leading Alzheimer's researchers.

A model of a human brain inside of a clinic. Next Avenue, Kisunla, new Alzheimer's drug
The newly approved drug Kisunla falls into a class of Alzheimer's treatments that target amyloid plaque, a protein buildup that leads to cognitive decline.  |  Credit: Jesse Orrico

"Alzheimer's disease is a very specific cause of cognitive impairment where you have the abnormal accumulation of a couple of proteins, such as amyloid and tau," says Chad Hales, M.D., an assistant professor of neurology at Emory University. This protein accumulation causes brain cells to get sick and die off, leading to Alzheimer's.

The disease can be divided into three main stages:

  • Mild or early: There are some signs of cognitive impairment, such as forgetting some memories or getting lost, but individuals can accomplish the majority of daily tasks without help.
  • Moderate: Memory loss and cognitive impairment grow worse in this stage. Someone with moderate Alzheimer’s may have trouble recognizing loved ones, correctly identifying smells and sounds, and completing multi-step tasks, like getting dressed. Hallucinations and paranoia may begin during this stage as well.
  • Severe: When Alzheimer's is severe, people cannot communicate with others or care for themselves. Usually, someone with severe Alzheimer's spends the majority of time in bed as their body shuts down.

Hales adds that the disease typically lasts 10 to 15 years. However, the condition's duration varies, depending on the disease's progression and a patient's age. Someone diagnosed at 84, for example, may only live three to four years longer while someone diagnosed at 60 may live for 15 more years.

Current treatment options

Currently, there isn't a cure to Alzheimer's or a way to prevent it. There are, however, three classes of medication that can help manage symptoms or slow the disease's progression.

The first and best-established class of drugs manage specific symptoms, such as depression or hallucinations, Hale says. The exact drugs prescribed for symptom management differ on a case-by-case basis.

Cholinesterase inhibitors are the second class of drugs on the market. These are prescribed to manage symptoms of mild or moderate Alzheimer's. Galantamine, rivastigmine and donepezil are the three most common drugs in this class.

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The third, and newest, class is immunotherapy drugs prescribed during the earliest stage of Alzheimer's. This is the class where the recently approved Kisunla fits in, but it's not the first.

"The first one to be FDA approved was called aducanumab, and that drug had unclear benefits and high rates of side effects. It is no longer available in the United States. The second FDA approved drug in this class is quite a good drug, and it's called Lecanemab," says Andrew Budson, M.D., a professor of neurology at Boston University Chobanian & Avedisian School of Medicine and the Chief of Cognitive Behavioral Neurology and the Director of the Center for Translational Cognitive Neuroscience at the Veterans Affairs Boston Healthcare System. 

"Kinsunla, in and of itself, is not an amazing breakthrough. It's this class of drug that's an amazing breakthrough."

He explains that the third class of drugs targets amyloid plaque, protein buildup that leads to cognitive decline, in order to slow Alzheimer's progression. While someone can only take one drug in this third class, Lecanemab or Kisunla can be paired with medications from the other two classes.

What is Kisunla?

Kisunla is a monthly treatment, delivered via a 30-minute infusion. In the first three months of treatment, 700 mg of the drug is administered. Then, 1,400 mg is prescribed for the remaining months in the treatment plan. After an infusion is complete, patients are kept for at least 30 minutes to ensure there are no adverse reactions.

"Kinsunla, in and of itself, is not an amazing breakthrough. It's this class of drug that's an amazing breakthrough," Budson says. The difference between the two FDA-approved drugs in this class, Lecanemab and Kisunla, are the drugs' targets.

Lecanemab targets protofibrils and fibrils, two main components of amyloid plaque, while Kisunla targets amyloid plaques more broadly. Both drugs accomplish the same goal: to slow cognitive decline and stabilize Alzheimer's symptoms.

Kisunla's manufacturer reports the drug can reduce cognitive decline by over 35% in 76 weeks in patients with early stage Alzheimer's. The key, however, is that the drug works in the earliest stage.

Budson explains that in the early stage of the disease, "someone can prepare meals, go grocery shopping and take their medications all by themselves, without additional help."

He outlines three criteria many doctors use to categorize early stage Alzheimer's:

  • Family, loved ones or a doctor have expressed concerns about impaired memory.
  • The individual completes a cognitive function test, and the results demonstrate some cognitive impairment.
  • Despite demonstrated cognitive impairment, the individual can complete most daily activities without help.

While effective, Kisunla is not without side effects. The most common ones, according to the drug's manufacturer, include:

  • Headaches
  • Dizziness
  • Nausea
  • Trouble walking
  • Confusion
  • Vision changes
  • Inflammation
  • Brain swelling

"My expectation is, within the next one to two years, these blood tests will be routinely used to confirm that Alzheimer's disease is present."

If severe, brain swelling can lead to more serious side effects, such as a stroke or seizure. Medicines to reduce swelling, including over-the-counter options like Tylenol, work well for most patients, adds Budson, but there is always a risk of more serious complications.

"Kisunla is already being shipped to infusion centers, so if a person is interested in receiving it or believes they may have early symptomatic Alzheimer's disease, the best thing they can do is speak to their doctor," explained a representative of the drug's manufacturer, Eli Lilly, in an email.

While available to the public, not all health insurance plans cover Kisunla's cost. If on a private plan, including a Medicare Advantage plan, check with a provider about coverage and costs. Original Medicare usually covers Kisunla, and the drug's manufacturer expects Medicare Part B will cover the cost of treatment for 98% of patients.

Alzheimer's care is evolving, and there are some exciting studies being conducted around how to screen for and treat this condition. Blood tests, for example, are currently being developed in order to diagnose Alzheimer's with a higher degree of certainty. "My expectation is, within the next one to two years, these blood tests will be routinely used to confirm that Alzheimer's disease is present," Budson says.

"The most important lifestyle intervention is probably engaging in regular aerobic exercise."

Budson also mentions that experimental treatments, such as altering the gut microbiome or inducing different brain rhythms, are being tested against Alzheimer's. Most, if not all of these treatments, are highly experimental. These trials are ongoing, meaning they are not viable treatment options right now.

Lifestyle interventions

While pharmaceutical treatments are available, brain-healthy habits may prevent or slow Alzheimer's too. Specific lifestyle habits that have been identified as helpful to prevent or slow Alzheimer's include:

  • Aerobic exercise: “The most important lifestyle intervention is probably engaging in regular aerobic exercise,” Budson says. Walking for 20 minutes a day can help lower the risk of Alzheimer’s, according to a 2023 study.
  • Eat healthy: Cutting down on processed foods and eating more whole foods may boost cognitive health. The Mediterranean diet, which is high in vegetables, legumes, fruits, nuts and fish, may be especially beneficial to those looking to lower the risk of Alzheimer’s or slow the disease.
  • Get enough sleep: Sleep deprivation may speed up Alzheimer’s progression, according to a recent study. The CDC recommends adults sleep at least seven hours a night.
  • Keep your brain active: Engaging in regular social activity and cognitive challenges is easier if you’re still working. “If you're already retired, finding ways to keep your brain active, whether it be socializing with colleagues or volunteering, is important and should be intentional,” Hale says.
  • Socialize: A 2024 study suggests loneliness may deplete cognitive and sensory stimulation, increasing the chances of multiple types of dementia, including Alzheimer’s. To combat loneliness, make regular time to socialize with friends and loved ones.

These brain-healthy habits compound over time and work better together. "The amount of improvement from one lifestyle change is probably tiny," Hale explains, "but if you start to add a lot together, it may be quite helpful."

While scientists have yet to find a treatment that reverses or prevents Alzheimer's, the number of medications to slow the disease and manage symptoms is growing. Plus, researchers are finding more evidence to support lifestyle interventions as a way to lower the risk of Alzheimer's. Both developments provide hope for individuals with Alzheimer's and their loved ones.

Angela Myers
Angela Myers is a freelance health writer covering aging, nutrition and mental health. Her work has appeared in Forbes Health, AARP and Well+Good, among others. Read More
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