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BONITA SPRING, FL, January 10, 2023 — Memory Treatment Centers are pleased to announce that the Food and Drug Administration (FDA) has approved Lecanemab, a new drug for the treatment of Alzheimer’s disease. This is an important milestone in the fight against Alzheimer’s disease, a progressive brain disorder that causes memory loss, communication difficulties, and behavioral changes.
“The accelerated approval of Leqembi signifies a historical step in the treatment of a disease that has altered the lives of millions of Americans and their loved ones,” explained Dr. Jamie Plante of Memory Treatment Centers of Bonita Springs. “We now have clinical trial data that demonstrates Leqembi can slow the progression of Alzheimer’s disease.”
Lecanemab is designed to reduce the production of amyloid beta, a protein that accumulates in the brains of people with Alzheimer’s and is thought to play a role in the development of the disease. By reducing the production of amyloid beta, the thesis is that Lecanemab will help to slow the progression of Alzheimer’s and improve symptoms in patients.
“Through decades of Alzheimer’s research, we have learned that amyloid beta plaques are an early hallmark feature of the disease and play a large role in the propagation of brain cell death, cognitive impairment and loss of memory” stated Dr. Samuel Giles of Memory Treatment Centers of Jacksonville.
“Leqembi has demonstrated the ability to successfully remove amyloid beta plaques which slows the progression of memory loss. We saw a similar ability to remove the amyloid plaques with Aduhelm, but now finally have indisputable evidence that the removal of these plaques clearly results in a slowing of the cognitive decline.”
This approval is based on the results of clinical trials that showed Lecanemab to be safe and effective at reducing amyloid beta production and improving cognitive function in patients with Alzheimer’s. The drug will be available by prescription, and we are excited to work with our patients to determine if it is an appropriate treatment option for them.
“Early intervention and treatment are very important with Alzheimer’s disease, and when using Leqembi. This is a tool to help prevent the progression of memory loss from Alzheimers, and cannot be given to those with more severe memory impairment.” added Dr. Donald McCarren of Memory Treatment Center of Bonita Springs.
“We already have numerous current Alzheimer’s Disease patients at Memory Treatment Centers who will be treated with this groundbreaking therapy and are hopeful that we will be able to serve and treat countless more with this efficacious treatment” concluded Dr. Robert Mannel of Jacksonville.
Memory Treatment Centers are committed to finding and utilizing new and innovative treatments for Alzheimer’s and other neurological conditions, and we are pleased to have Lecanemab as a new tool in our arsenal. We encourage patients and their families to contact a Memory Treatment Center provider about the potential benefits of Lecanemab and other treatment options.
If you are a patient and have further questions about treatment opportunities, please contact our Bonita Springs or Jacksonville clinics.
A: On January 6th, 2023 the FDA granted accelerated approval for Lecanemab (Leqembi) which is the second FDA approved therapy for Alzheimer’s disease that specifically targets protofibrils which cluster together and form the protein plaque beta-amyloid 42. This protein is involved in the pathology of Alzheimer’s disease by forming plaques which lead to memory loss and brain cell death. The approval of Lecanemab has now allowed healthcare providers like neurologists and neurocognitive specialists, to become proactive in treating and preventing the progression of Alzheimer’s disease.
A: Lecanemab targets beta-amyloid42 protein (specifically protofibrils – which are smaller proteins that bind together and form the plaques) and removes these from your brain. Studies have shown that these protein plaques are one of the hallmark processes that occur early-on in Alzheimer’s disease and their presence plays a pivotal role in Alzheimer’s dementia. By removing these plaques, clinical trials have shown that Lecanemab slows progression of the disease by an average of 27% (some patients had even greater benefit).
A: At this time, there is no clinical data from the FDA trials to suggest Lecenamab restores prior memory or cognitive function. Rather, the available FDA data provides support that Lecanemab slows progression of Alzheimer’s disease and preserves and extends independence both cognitively and physically.
A: Lecanemab is approved for the treatment of confirmed Alzheimer’s disease patients with either mild dementia, or for individuals with mild cognitive impairment (MCI); often a precursor state to Alzheimer’s dementia. Patients with moderate or severe Alzheimer’s dementia are unfortunately not eligible for this therapy. This criteria is in accordance with the population studied in the clinical trials.
A: Your Neurocognitive specialist will perform a thorough assessment to determine whether or not a given individual is a candidate for Lecanemab.
A: Along with in-office assessments and neuropsychological evaluations, a sample of cerebrospinal fluid (CSF) or use of amyloid PET (Positron Emission Tomography) brain scans are used to confirm the presence of the abnormal protein beta-amyloid-42 in the brain.
A: Either an Amyloid PET (Positron Emission Tomography) scan or a lumbar puncture (also known as a spinal tap) are used to obtain cerebrospinal fluid (CSF) to confirm the presence of the abnormal protein beta-amyloid 42 plaque. Your neurocognitive specialist will help guide you in determining which of these is the best study for you.
A: Lecanemab is administered via an IV (intravenous) infusion that is performed once every 2 weeks. The infusion will last 45-60 minutes and is very well tolerated. We are still learning about how long (how many months) patients will require treatment and whether a maintenance treatment will be required. We will provide updates as more information becomes available.
A: The most common side effects associated with Lecanemab treatment are amyloid related imaging abnormalities (ARIA) followed by headache, dizziness, confusion and falls. ARIA is a result of the removal of the amyloid protein plaques (the desired effect of Lecanemab treatment) and usually does not result in any symptoms. The ARIA may result in either a temporary small area of swelling or very small bleeds (microbleeds) which most often resolve on their own and without any need for intervention. You will be monitored for ARIA side effects throughout treatment, including with brain imaging which is covered by insurance.
A: While amyloid related imaging abnormalities (ARIA) are seen in approximately 21.3% of those receiving the Lecanemab infusions, less than 3% developed any clinical symptoms from their ARIA ( 2.8% and 1.4% for ARIA-E and ARIA-H, respectively). Serious adverse events were less than 1% for both types of ARIA in this trial.
A: At this time, both Medicare and Commercial insurance have not made determinations on whether they will cover Leqembi. Therefore, the drug is currently available as a self-pay option and costs a total of $26,500 a year (~$2209 at month). A patient assistance program and application can be found at:
https://www.eisaireimbursement.com/patient/leqembi/support-programs
A: Currently, there is one additional FDA approved anti-amyloid therapy available called Aducanumab (Aduhelm). Based on the available clinical trial data for Aducanumab and Lecanemab, we recommend Lecanemab at this time based on both efficacy and safety profiles. This medication (aduhelm) is also not currently covered by insurance.