New drug within the fight against Alzheimer’s disease: Lecanemab (Leqembi®)

Alzheimer’s disease (AD) affects over six million people within the United States. As a nurse, you’ll likely receive questions from friends and relatives about Alzheimer’s disease and its potential treatment options. (Lequembi®) is the latest drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer’s disease.
AND

Pathophysiology of Alzheimer’s disease

Let’s start with an summary of the pathophysiology of Alzheimer’s disease. The exact mechanism of Alzheimer’s disease will not be known, nevertheless it prevents the brain’s nerve cells from functioning effectively, resulting in everlasting changes within the brain. Alzheimer’s disease patients appear to have lower levels of choline acetyltransferase, leading to reduced acetylcholine synthesis and impaired cortical cholinergic activity, processes essential for learning, memory, and cognitive function (Press & Buss, 2021). Additionally, the event of plaques and tangles within the brain contributes to neuronal damage. Plaques are deposits of beta-amyloid proteins that accumulate within the spaces between nerve cells, while tangles are twisted filaments of tau proteins that accumulate in cells. These proteins block communication between neurons and play a job in cell damage, resulting in mental deterioration. This process naturally occurs in most of us as we age, but in individuals with Alzheimer’s disease, there may be an increased accumulation of plaques in areas of the brain accountable for memory function.
AND
AD is characterised by progressive memory loss and cognitive decline that interfere with each day activities. Advanced symptoms include confusion; changes in mood and behavior; confusion about events, time and place; false suspicious feelings; and difficulty speaking, swallowing, and walking (Alzheimer’s Association, n.d.). There is not any cure for Alzheimer’s disease, but advances in research have led to the approval of several medications which were shown to slow the progression of the disease. Cholinesterase inhibitors have been available because the late Nineties and are sometimes the first-line treatment for mild to moderate Alzheimer’s disease. Three of them are currently available within the US: galantamine (oral), rivastigmine (oral and transdermal), and Donepezil (Aricept®) (oral and transdermal); all work by increasing acetylcholine levels. Memantine (Namenda®), an N-methyl-D-aspartate (NMDA) receptor antagonist, was approved in 2003 for the treatment of symptoms of moderate to severe Alzheimer’s disease. Both classes of medicines have been shown to provide small improvements in cognition, neuropsychiatric symptoms, and activities of each day living (Press & Buss, 2021), but individual patient responses are highly variable.
AND

NEW! Monoclonal antibodies

The FDA has approved two monoclonal antibodies to slow the progression of Alzheimer’s disease in patients with mild disease: Aducanumab (Aduhelm®) in 2021 and most recently druganemab (Leqembi®) in July 2023. Both treat and take away specific sorts of beta amyloid proteins that transform into plaques within the brain, but they act otherwise at different stages of plaque formation (Alzheimer’s Association, n.d.). Clinical efficacy data from clinical trials with aducanumab are limited and conflicting. Lekanemab met all primary and secondary efficacy endpoints, meaning it showed significant clinical results. For the needs of this blog, we’ll concentrate on lekanemab.
AND

Frequently asked questions on Lecanemab (Leqembi®).

Since lekanemab is recent to the market, you’ll likely receive many inquiries. Below are ceaselessly asked questions and straightforward answers you possibly can share together with your patients, family and friends.
AND

For early stages of Alzheimer’s disease (mild cognitive function), on the discretion of your physician, druganemab could also be a treatment option. To confirm the presence of beta amyloids within the cerebrospinal fluid, a positron emission tomography (PET) scan or lumbar puncture (lumbar puncture) will probably be crucial. Additionally, it might be advisable to check for a variant of the apolipoprotein E gene called APOE4. About 25% of individuals carry one copy of APOE4, and a couple of to three% carry two copies. APOE4 is probably the most potent AD risk factor gene and may result in serious negative effects (Bryan, 2021).
AND

Lekanemab won’t cure Alzheimer’s disease or improve memory or cognition. In research studies, druganemab slowed cognitive decline by 27% after 18 months in comparison with placebo, nevertheless it didn’t completely prevent the worsening of Alzheimer’s disease.
AND

Lekanemab is run intravenously (IV) once every 2 weeks. Treatment will probably be stopped when there may be evidence of progression to moderate or severe stages of Alzheimer’s disease.
AND

Before initiating treatment with lekanemab and periodically during treatment, it’s crucial to perform magnetic resonance imaging (MRI) of the brain to discover potential negative effects.
AND

Lekanemab may cause diarrhea and cough. It is vital to closely monitor for signs of infusion response, similar to fever, chills, aches, tremors, arthralgia, high or low blood pressure, headache, vision changes, or allergic response.
AND

Lekanemab may cause mild to moderate cerebral swelling or bleeding (microhaemorrhages), which can resolve by itself or could also be life-threatening. These risks are called amyloid-related imaging disorders (ARIA). This may lead to irregular gait, dizziness, focal neurological deficits, headache, nausea and visual disturbances. People taking blood thinners and folks who’ve the APOE4 gene (especially two copies) are at increased risk of those negative effects.
AND

As of this writing, the associated fee of lekanemab is $26,500 per yr. You also needs to consider the extra cost of standard clinic visits, periodic MRIs, and other required tests.
AND

Private insurance won’t cover lecanemab, nonetheless, Medicare will cover 80 percent of the associated fee for Medicare enrollees diagnosed with mild cognitive impairment or mild dementia related to Alzheimer’s disease, with documented evidence of beta-amyloid plaques within the brain. and is currently being treated by a provider who participates in a qualifying registry with an appropriate clinical team and follow-up care (Centers for Medicare and Medicaid Services [CMS], 2023). The registry is a set of knowledge on the results of those drugs outside of clinical trials.
AND
In conclusion, although these drugs offer a glimmer of hope within the fight against Alzheimer’s disease, it will be important to emphasise that these drugs don’t provide a cure. Patients and their families should seek the advice of their physician to rigorously consider the risks and advantages and to find out whether lekanemab or other treatments are clinically appropriate.
AND

Alzheimer’s Association (n.d.). What is Alzheimer’s disease? Retrieved July 19, 2023 from https://www.alz.org/alzheimers-dementia/what-is-alzheimers

AND
Bryant, E. (2021, March 16). Study shows how the APOE4 gene may increase the danger of dementia. https://www.nia.nih.gov/news/study-reveals-how-apoe4-gene-may-increase-risk-dementia

AND
Centers for Medicare and Medicaid Services (2023). Disclaimer: Broader Leqembi Medicare coverage available after traditional FDA approval. https://www.cms.gov/newsroom/press-releases/statement-broader-medicare-coverage-leqembi-available-following-fda-traditional-approval

AND
Press, D., & Buss, S. (2021, September 30). Treatment of Alzheimer’s disease. . https://www.uptodate.com/contents/treatment-of-alzheimer-disease

AND
AND