BONITA SPRINGS, Fla., July 17, 2024 /PRNewswire/ -- Since last year, Memory Treatment Centers (MTC) has been a leading provider of the novel Alzheimer's treatment, Leqembi, providing hundreds of patients with the first-ever proactive approach to treating and preventing progression of the disease. Now, MTC continues to innovate in neurocognitive care by giving Alzheimer's disease (AD) patients additional treatment options. Through its national network of partners with Pure Infusion Suites, MTC is now offering access to the recently FDA-approved therapy, Kisunla (donanemab).

"The full traditional FDA approval of Donanemab not only marks the advent of a new class of disease modifying therapy but signifies the neurodegenerative community's dedication to changing the way we view and treat Alzheimer's disease" encouraged Dr. Samuel Giles of Memory Treatment Centers Jacksonville. "We feel we have momentum towards offering true hope to our Alzheimer's patients and caregivers and note the ongoing cohesive collaborations between clinicians, researchers, biotech and pharmaceutical organizations is at an all-time high."

Kisunla: A Second Option to Treat Alzheimer's

On July 2^nd, the FDA granted a long-anticipated approval of Kisunla (Donanemab), marking the start of a new class of drugs designed to tackle beta-amyloid buildup in those with AD.

The FDA was expected to decide in March but delayed approval to gain more insight from the advisory panel about potential side effects. The treatment is associated with amyloid related imaging abnormalities (ARIA) which is a consequence of plaques being removed. The FDA advisory panel voted unanimously on the efficacy of Kisunla for the treatment of early AD.

While ARIA-related side effects were observed in a minority of patients, serious complications occurred in only 1.6% of people. With Alzheimer's leading to reliance on caregivers, eventual fatality, and 13 million expected to be diagnosed by 2050, the ability to target a root cause of cognitive decline vastly outweighed the risk of side effects.

MTC has reported no issues thus far in administering Kisunla. The clinical team understands the risks of ARIA and is working tirelessly to ensure patient safety. Clinics are using the most up to date imaging techniques and indicators, such as blood-based biomarkers, to assess patients' disease progression and response to therapy.

While Kisunla is similar to the treatment Leqembi, Kisunla is the only amyloid-plaque targeting therapy that uses a limited duration treatment cycle. The treatment is given as a biologic infusion every four weeks. It can be stopped once amyloid-plaque levels reach a certain threshold. Some patients were able to stop treatment after only six months, with most patients ending treatment by the 18-month mark.

The advent of Kisunla creates exciting opportunities in determining which preventative treatments are most effective for certain patients based on factors like genetics, disease progression, and age. More treatment options also allow for a collaborative approach to healthcare.

"The ability to now have therapeutic options to choose from allows for improved patient/provider shared decision making. We've seen our patients and caregivers want to be informed about their disease and available therapeutics, and we now will be able to provide more guidance" stated Dr. Donald McCarren of MTC in Bonita Springs. 

Who is considered a good candidate for Kisunla?

Specific factors that may decide if Kisunla or Leqembi is more effective in certain segments are being continually evaluated and will require more time before key insights are known. However, Kisunla initially offers comparable results with a less disruptive treatment schedule, and for some may be more efficacious.

While Leqembi requires continual infusions every two weeks, Kisunla is infused once a month and can be stopped when amyloid levels are low enough. Research has shown that it may take up to four years for amyloid plaque levels to reappear in which patients will be re-dosed at that time.

This type of medicine does not restore previous levels of cognitive function, it only slows the progression of cognitive decline by reducing amyloid plaques. Therefore, it is crucial that treatment begins as early as possible.

Dr. Jamie Plante of Memory Treatment Centers Bonita Springs added "We have just begun to explore the real-world longitudinal benefits with these therapies and identify who best will be served by each. Through continued clinical and academic evaluation, we are excited to learn more about managing the disease process from a preventative standpoint." 

To be approved for treatment, patients must be evaluated by a healthcare provider for either mild dementia, or mild cognitive impairment (MCI), a precursor state to Alzheimer's dementia. Patients with moderate or severe Alzheimer's dementia are unfortunately not eligible for this therapy, due to the preventative nature of treatment.

Cognitive Impairment: Signs and Symptoms of Cognitive Impairment

Cognitive impairment is often signaled by minor changes in memory and communication. Changes in lifestyle are also common, like ability to maintain work duties, social relationships, or keep routines.

Many people with early cognitive impairment (mild cognitive impairment) continue to work and socialize as usual but begin to note a slight difference in their ability to manage daily life. Family or friends may notice these differences as well.

As cognitive function declines, an individual may progress from MCI to more advanced stages of dementia. Several factors contribute to the development of MCI and dementia which underscores the critical role of a comprehensive neurocognitive assessment to diagnose early symptomatic AD timely and accurately.

What Type of Specialist Diagnose Cognitive Impairment, Dementia, and Alzheimer's Disease?

Despite a vast majority of physicians acknowledging the importance of diagnosing AD in the earliest stages of MCI and mild dementia, making an accurate early diagnosis is no easy task.

A Neurologist specializing in neurocognitive medicine has the ideal skills necessary to evaluate patients for MCI. Unfortunately, a mere fraction (~5%) of Neurologists specialize in neurocognitive medicine, posing substantial barriers to timely evaluation and care.

As the annual incidence of AD continues to rise, this presents a critical challenge to our healthcare system at large. This results in costly delayed diagnoses which will severely limit the effectiveness of the new preventative treatments.

Dr. Robert Mannel of Memory Treatment Centers Jacksonville added "We are moving towards being able to determine which therapeutics are most likely to be the most efficacious based on genetic factors, symptomatic disease stage and age. We are thrilled about the most recent approval with Donanemab and look forward to additional therapeutics coming down the pipeline in the near future". 

Where can I be evaluated for MCI, mild dementia, AD, and treatment?

Patients affected by cognitive impairment from early symptomatic AD and who may qualify for a preventative treatment like Kisunla can generally undergo neurocognitive evaluations via telehealth from anywhere in the US. If you're in Florida, please visit one of the MTC facilities.

At MTC, we provide comprehensive evaluations via our neurocognitive specialists to assess the presence of cognitive impairment. We also utilize up-to-date biomarker testing to pinpoint the diagnosis. Our goal is to thoroughly evaluate and accurately diagnose our patients in a comfortable, streamlined, and friendly environment. Through this process, we can design a care plan that reflects each individual patient and family's goals and wishes.

All of us at MTC are dedicated to bringing hope and relief to patients with all types of cognitive impairment, including Alzheimer's Disease. If you or a loved one are interested in finding out if Kisunla or Leqembi is right for you, we are accepting new patients and are eager to assist you on your journey to better health.

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