Neurodegenerative Disorders
A New Hope for Alzheimer’s Patients Arrives at the Start of 2023
Lecanemab, a new Alzheimer’s medication, has been approved by the FDA, coming at half the price of Aduhelm, released in 2021.
This post summarizes the impact and implications of recent critical health news and provides tips for lowering the risk of Alzheimer’s.
By understanding the latest developments in the field of health and wellness, you can make informed decisions about how to protect and improve your brain and mental health.
My goal is to inform and inspire you to take proactive steps to lower your risk of developing Alzheimer’s and other neurodegenerative disorders with lifestyle choices and support from qualified healthcare professionals.
Noteworthy progress from 2021 to 2023
In 2021 I wrote an article when FDA approved Aduhelm, which was a unique drug at the time. It was developed and marketed by Biogen. But Aduhelm created concerns from an economic perspective as it needed to be cheaper to start with.
The price was $56,000 per year. Thousands of underprivileged people couldn’t afford it. This health equity issue created severe concerns. Medicare has limited coverage of Aduhelm.
Fortunately, a new drug comes at almost half price giving hope to millions of Alzheimer’s Patients globally through the leadership of Eisa and Biogen.
In this story, I introduce Leqembi, which is a new drug, that was approved for use in patients with Alzheimer’s disease under the FDA’s Accelerated Approval pathway on 6 January 2023. This pathway allows for the approval of drugs for severe conditions with unmet medical needs.
Leqembi is priced at $26,500 per year. Eisai said Leqembi might be covered by Medicaid under a post-accelerated approval process by also acknowledging that Medicaid coverage is decided state by state.
Dementia is a severe health condition that affects millions of people worldwide and impairs their quality of life. Alzheimer’s disease is the most common form of dementia, affecting approximately 6.2 million Americans.
While aging is a significant risk factor for developing dementia, research has shown that lifestyle factors also contribute to the risk of developing this condition.
Symptoms of dementia include memory loss and changes in personality. There is currently no cure for dementia, but researchers have developed medications that may help to address the underlying causes of the condition, such as biological defects and nutritional deficiencies.
By making lifestyle changes and taking appropriate medication, it may be possible to reduce the risk of developing dementia, as I explained at the end of this story.
What is Leqembi, and why does it matter?
Leqembi, a new Alzheimer’s drug developed by Eisai and Biogen, was approved by the Food and Drug Administration (FDA) on 6 January 2023. This medication was developed by Eisa, a Japanese company founded in 1923.
It is great news that Leqembi, which is a new drug, was approved for use in patients with Alzheimer’s disease under the FDA’s Accelerated Approval pathway. This pathway allows for the approval of drugs for severe conditions with unmet medical needs.
The drug has shown an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit for patients.
Researchers conducted a double-blind, placebo-controlled study on 856 patients with Alzheimer’s disease. They found that treatment with Leqembi resulted in a statistically significant reduction of brain amyloid plaque in patients receiving the approved dose of 10 milligrams/kilogram every two weeks.
Leqembi is intended for use in patients with mild cognitive impairment or early-stage Alzheimer’s disease with evidence of beta-amyloid pathology.
It is administered intravenously at a recommended dosage of two infusions per month. Intravenous means that medication is distributed directly into a vein.
The drug may take some time to show an effect, as demonstrated in clinical trials where no benefit was observed after a year of treatment.
The prescribing information for Leqembi includes a warning for amyloid-related imaging abnormalities (ARIA) and infusion-related reactions.
ARIA, which usually does not have symptoms but can occasionally be severe or life-threatening, is characterized by swelling in the brain and may be accompanied by tiny spots of bleeding. It may be symptomatic in a small percentage of cases.
Infusion-related reactions can include flu-like symptoms, nausea, vomiting, and changes in blood pressure. The most common side effects of Leqembi were infusion-related reactions, headache, and ARIA.
Leqembi aims to treat Alzheimer’s disease in patients with mild cognitive impairment or mild dementia. There is currently no data on the safety or effectiveness of using Leqembi in patients at earlier or later stages of the disease.
Christopher A. Viehbacher, President and Chief Executive Officer of Biogen, said, “Today’s filing is an important milestone for people living with Alzheimer’s disease, demonstrating the resilience of the scientific and medical communities in their fight against this terrible disease despite the many setbacks and the challenges they’ve faced.”
Eisa posted a news release on 7 January 2023. You can learn more about Leqembi from the official document of Eisa in this publicly available PDF document.
Overview of the Clinical Trial for Lecanemab
The clinical trial funded by Eisai and Biogen was published in the New England Journal of Medicine on 5 January 2023.
The paper’s title is “Lecanemab in Early Alzheimer’s Disease.” I’d like to briefly summarize this important double-blind study. Here is the summary with critical information.
In a double-blind, phase three clinical trial, researchers evaluated the efficacy of Leqembi in patients with early Alzheimer’s disease.
A total of 1795 participants were enrolled, with 898 assigned to receive Lecanemab and 897 to receive a placebo.
The trial included patients between the ages of 50 and 90 with mild cognitive impairment or mild dementia due to Alzheimer’s disease and evidence of amyloid on positron emission tomography or by cerebrospinal fluid testing.
Participants were randomly assigned to receive either Leqembi or a placebo, with the primary endpoint being the change in Clinical Dementia Rating-Sum of Boxes scores at 18 months.
Key secondary endpoints included the change in the amyloid burden on PET scans, scores on the Alzheimer’s Disease Assessment Scale cognitive subscale, the Alzheimer’s Disease Composite Score, and the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment.
Leqembi was administered intravenously at a dose of 10 mg per kilogram of body weight every two weeks. The trial lasted for 18 months.
The primary endpoint of the study was the change from baseline at 18 months in the Clinical Dementia Rating-Sum of Boxes scores, with higher scores indicating greater impairment.
Secondary endpoints included the change in the amyloid burden on PET scans, scores on the Alzheimer’s Disease Assessment Scale cognitive subscale, the Alzheimer’s Disease Composite Score, and the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment.
Overall, the trial aimed to assess the effectiveness of Leqembi in slowing the progression of Alzheimer’s disease and improving cognitive function in patients with early-stage disease.
The results of this clinical trial are essential in determining the efficacy of Leqembi as a treatment option for Alzheimer’s disease and will be closely monitored by the FDA and the medical community.
Researchers concluded that:
“Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events. Longer trials are warranted to determine the efficacy and safety of Lecanemab in early Alzheimer’s disease.”
You can get more information about this clinical trial #NCT03887455 from the US government website.
An Alarming News from a Peer-Reviewed Journal
When I researched the recent updates, I came across this critical correspondence from the New England Journal of Medicine on January 4, 2023.
The report informed that “A patient with mild cognitive impairment who was treated in the extension phase of a trial of Lecanemab, an anti-amyloid compound, had multiple cerebral hemorrhages during infusion of t-PA for acute stroke.”
While Leqembi has shown promise in reducing the amyloid burden and improving cognitive function in early-stage Alzheimer’s disease during the clinical trial, more research is needed to fully understand its effects and potential risks.
Practical Tips to Slow Down Dementia
Medications can be an essential tool in treating various conditions, but it is also important to address lifestyle factors that can increase the risk of developing neurodegenerative disorders, such as dementia, particularly Alzheimer’s disease.
As I have been researching the impact and implications of neurodegenerative disorders since the mid-1980s, I’d like to summarize practical points to inspire my readers. Here are ten practical steps you can take to help reduce your risk:
1 — Lower Oxidative and Emotional Stress
Oxidative stress occurs when the production of reactive oxygen species (ROS) exceeds the body’s ability to neutralize them, leading to cellular damage. ROS are produced during normal cellular metabolism.
Chronic stress, which is often induced by negative emotions, can have significant detrimental effects on the brain. Research has consistently demonstrated a link between chronic stress and an increased risk of developing dementia.
One possible explanation for this association is that chronic stress leads to elevated levels of the stress hormone cortisol, which can impair melatonin production and cause sleep deprivation. This can have a cumulative negative impact on overall health.
Emotional stress, which is characterized by intense or destructive emotions such as fear, anxiety, anger, and grief, can also interfere with the body’s natural energy flow and balance, leading to a range of health issues.
It is essential to address and manage oxidative and emotional stress leading to chronic inflammation to maintain overall physical and mental well-being.
2 — Lower chronic inflammation.
Inflammation is a critical component of the body’s immune response, but chronic inflammation can be detrimental to overall health, particularly in the brain.
Many neurological diseases have been linked to persistent low-grade inflammation. While acute inflammation is necessary for the healing process following injury, chronic inflammation can lead to adverse health outcomes.
It is essential to address and manage chronic inflammation to maintain good health and prevent the development of various diseases. I documented my perspectives and experiences in an article titled Here Is How I Defeated Chronic Inflammation via 9 Lifestyle Habits.
3 — Address nutritional issues
There are certain essential nutrients that our bodies and brains require to function correctly. These include amino acids, essential fats, minerals, and vitamins.
While glucose is necessary for the brain and some organs as an energy source, the body can create its own glucose through a process called gluconeogenesis, meaning that carbohydrates are not essential in the same way.
Individual choices and experiences may vary, but excessive glucose in the bloodstream can lead to insulin resistance and metabolic syndrome, which have been linked to neurodegenerative diseases such as Alzheimer’s disease.
An alternative energy source, ketones, can provide a cleaner energy source for the brain. It is vital to maintain a sufficient intake of minerals and specific vitamins, including Vitamin D, magnesium, and zinc.
4 — Create new neural pathways via exercise.
Physical activity is essential for both physical and mental health.
Certain types of exercise, such as aerobic exercise, have been shown to increase the production of BDNF, a protein involved in the growth and maintenance of neurons.
Exercise can also help to remove toxins from the body and produce “feel-good” hormones and neurochemicals that can contribute to the formation of new connections in the brain.
It is essential to consult with a qualified healthcare professional when developing an exercise plan, as individual health conditions may need to be considered.
5 — Rest and get restorative sleep daily.
Adequate and restorative sleep is an essential component of overall health and well-being. It allows the body and brain to repair and restore themselves from daily wear and tear, which is necessary for proper functioning.
The amount of sleep that an individual needs may vary, but it is essential to ensure that the sleep obtained is of good quality and restorative. Sleep deprivation has been linked to dementia.
In a recent story, I shared practical tips that I personally found effective in solving sleep issues and improving my own sleep quality, including optimizing cortisol levels, which can be disrupted by stress and insomnia.
6 — Eliminate toxins and pathogens.
Exposure to toxins, heavy metals, and pathogens can disrupt the delicate balance of hormones in the brain and negatively affect brain chemistry. It is crucial to avoid smoking and excessive alcohol consumption.
While it is not possible to completely eliminate all toxins from the body, some strategies can help to reduce the levels of these substances. For example, using activated charcoal has been shown to be effective in removing heavy metals from the gut.
The body’s natural detoxification systems have limits, and if the levels of toxins exceed these limits, adverse health effects may occur. We have an alternative solution that I cover in #7.
To minimize the impact of toxins on overall health, it is essential to reduce exposure to these substances as much as possible, mainly through the air we breathe, the water we drink, and the food we eat.
7 — Initiate autophagy and mitophagy.
Autophagy is the body’s process of self-healing at the cellular level. It is a complex process involving the consumption of unnecessary or harmful cells, pathogens, and toxins as an energy source.
This process is activated under certain conditions, such as energy deficiency or the presence of pathogens. It has been studied for many years, but we are still learning about the key molecular steps involved in autophagy and mitophagy.
During this process, human cells, which are made up primarily of proteins and water, interact with pathogens such as viruses and fungi, activating specific genes. This interaction can be both synergistic and problematic.
You can learn more about autophagy and mitophagy from my previous articles, reflecting my decades of research and experience in the field.
8 — Create cognitive reserves with healthy lifestyle habits.
It is normal to experience some cognitive decline as we age, but dementia is not a necessary part of the aging process. We can improve brain health and prevent brain atrophy.
Dementia can be caused by various medical conditions and unhealthy lifestyle factors. However, it is possible to build up cognitive reserves through mental activities and exercises that can help to protect against cognitive decline.
Cognitive flexibility, the ability to adapt and change mental processes in response to new information or challenges, is an essential aspect of mental health and can be maintained through the use of everyday activities as mental boosters.
I provided five practical tips to create cognitive reserves to lower the risks and effects of neurodegenerative disorders such as Alzheimer's disease.
9 — Stop smoking and excessive alcohol use.
Smoking produces numerous harmful substances and impairs blood flow to the brain. While pure nicotine may have some potential cognitive benefits in low doses, the other chemicals present in cigarette smoke are dangerous.
Quitting smoking is a wise decision for health and well-being. The negative impacts of smoking have been widely recognized by healthcare professionals for many years, and many governments have implemented strict measures to protect their populations from the harm caused by cigarette smoke.
Excessive alcohol consumption also has adverse effects on brain health, and the high sugar content of some alcoholic drinks can contribute to insulin resistance, which has significant implications for health.
10 — Improve relationships and create meaningful connections with others.
Social connections are crucial for optimal brain development and overall well-being. As social beings, we have an inherent need for intimacy and connection with others, and this is reflected in the open structure of our limbic system.
Numerous studies, including those conducted in the so-called “Blue Zones,” have shown that individuals who are socially active and intelligent tend to live longer, and social connection is a well-established factor in longevity.
Our emotional maturity, or the ability to effectively manage and express our emotions, plays a crucial role in our social intelligence and ability to form and maintain meaningful relationships with others.
Summary of this Important Health News
Leqembi, a new medication for the treatment of Alzheimer’s disease, has been approved for use by the FDA under its Accelerated Approval pathway.
Developed by Eisai and Biogen, Leqembi is intended for use in patients with mild cognitive impairment or early-stage Alzheimer’s disease with evidence of beta-amyloid pathology.
In a clinical trial involving 856 patients with Alzheimer’s disease, treatment with Leqembi resulted in a statistically significant reduction of brain amyloid plaque at the recommended dosage of 10 ml/kg every two weeks.
Leqembi is administered intravenously, with two infusions recommended per month. It may take some time for the drug to show an effect, as no benefit was observed after a year of treatment in clinical trials.
The prescribing information for Leqembi includes warnings for potential infusion-related reactions and amyloid-related imaging abnormalities (ARIA).
Common side effects of the drug include infusion-related reactions, headache, and ARIA. There is currently no data available on the safety or effectiveness of using Leqembi in patients at earlier or later stages of the disease.
Leqembi is offered at a significantly lower price than the currently available treatment, Aduhelm. It is essential to discuss the potential risks and benefits of any medication with a healthcare professional before starting treatment.
Key Takeaways of the Story
The following lifestyle factors can improve the brain and mental health. You can customize them based on your goals and needs.
Consume whole foods for adequate energy and essential nutrients.
Engage in regular exercise daily, at least 150 minutes weekly.
Address oxidative and emotional stress and reduce chronic inflammation.
Get enough and restorative sleep nightly.
Minimize exposure to toxins and pathogens.
Improve relationships and develop meaningful social connections.
Avoid smoking, excessive alcohol consumption, and drugs.
Promote the natural activation of autophagy and mitophagy.
Build cognitive reserves through mental activity and exercise.
Improve hormonal balance and optimize neurotransmitters such as dopamine, serotonin, oxytocin, and GABA.
Obtain timely professional support for diagnosis and effective treatment of disorders, including medication, therapy, or surgery.
While medications can play a vital role in treating a range of conditions, it is also necessary to consider and address lifestyle factors that may increase the risk of developing neurodegenerative disorders, such as dementia, particularly Alzheimer’s disease.
These lifestyle factors, like dietary choices, physical activity levels, social connections, and other behaviors, can impact the brain and mental health.
By addressing these factors in addition to utilizing appropriate medications, it may be possible to improve overall health and reduce the risk of developing these severe and often debilitating conditions like Alzheimer’s disease.
Thank you for reading my perspectives. I wish you a healthy and happy life.
As a new reader, please check my holistic health and well-being stories reflecting my reviews, observations, and decades of experiments optimizing my hormones and neurotransmitters. I write about health as it matters. I believe health is all about homeostasis.
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