A Clinical Perspective on Emerging Alzheimer’s Medications: Donanemab and Lecanemab
What Is Donanemab?
Eli Lilly’s donanemab has recently gained attention as a potential breakthrough in Alzheimer’s drug treatment. This monoclonal antibody specifically targets a modified form of beta-amyloid plaque, a key hallmark of Alzheimer’s disease. By binding to these plaques, donanemab facilitates their removal from the brain, potentially slowing cognitive decline associated with the disease.
The TRAILBLAZER-ALZ trial has demonstrated that donanemab can significantly slow the progression of Alzheimer’s in patients with early symptomatic disease, showing a 32% reduction in cognitive decline over 18 months compared to a placebo. This promising result has sparked considerable optimism among researchers and clinicians.
Despite its potential, donanemab’s journey has not been without challenges. The FDA recently delayed its approval, citing the need for more data on its safety and efficacy. Notably, the drug has been associated with amyloid-related imaging abnormalities (ARIA), which can result in brain swelling and microhemorrhages. Furthermore, during clinical trials, there were reports of deaths potentially linked to ARIA, with at least three participants dying, highlighting the need for rigorous safety evaluations.
Donanemab’s initial rejection for accelerated approval by the FDA underscores the necessity for more robust evidence before widespread availability. Ongoing research and further clinical trials are essential to better understand its long-term effects and optimize therapeutic protocols.
Detailed information on the Phase 2 clinical trial of donanemab, including study design, participant qualifications, and trial objectives, can be found on this Alzheimer’s.gov page. More details are available here
What Is Lecanemab?
Developed by Eisai and Biogen, lecanemab is another monoclonal antibody showing promise in Alzheimer’s drug treatment. It targets soluble amyloid-beta aggregates in the brain, binding to protofibrils to prevent their aggregation and facilitate their clearance.
The Clarity AD trial indicated that lecanemab could reduce cognitive and functional decline by 27% over 18 months compared to a placebo. This trial included patients with early Alzheimer’s disease, and the results indicate significant slowing of disease progression.
In July 2023, lecanemab received traditional FDA approval, making it one of the few Alzheimer’s drugs approved for early-stage disease. It is intended for patients with mild cognitive impairment or mild Alzheimer’s dementia, confirmed by the presence of amyloid-beta plaques through diagnostic tests like PET scans.
Lecanemab is not without controversy. Safety concerns, particularly regarding ARIA, which can lead to brain swelling and microhemorrhages, have been significant. Additionally, the high cost of treatment and questions about the overall efficacy of amyloid-targeting therapies contribute to ongoing debates about the best approach to treating Alzheimer’s disease.
The National Institute on Aging (NIA) has provided a statement here about the Lecanemab trials.
A Holistic Perspective on New Alzheimer’s Drugs
Dr. Dale Bredesen, a renowned Alzheimer’s researcher, has been critical of traditional approaches that focus on amyloid plaque reduction, such as donanemab and lecanemab. He argues that the amyloid hypothesis is overly simplistic and does not address the multifactorial nature of Alzheimer’s disease. While these new Alzheimer’s drugs may slow cognitive decline, their effects are relatively modest, and the potential side effects pose significant risks.
Dr. Bredesen encourages a more comprehensive approach. One that involves assessing genetic, biochemical, and lifestyle factors and tailoring treatment plans to optimize brain health. This includes dietary changes, physical exercise, cognitive training, sleep optimization, and targeted supplementation. His protocol is how our Bredesen trained practitioners treat cognitive decline and Alzheimer’s here at Solcere.
Clinical studies of this type of holistic protocol have shown promising results, with significant improvements in cognitive function compared to the modest benefits observed with amyloid-targeting Alzheimer’s drugs.
The advancements in Alzheimer’s treatment, including the development of donanemab and lecanemab, offer new hope that research is ongoing in this area, but also come with challenges. Dr. Bredesen’s holistic approach represents a promising direction in dementia care, emphasizing the potential of integrating lifestyle changes and personalized medicine to improve the quality of life for those affected by dementia.
Learn about Solcere’s Bredesen-informed services here.
Common Questions About the New Alzheimer’s Drugs
What are the side effects of new Alzheimer’s drugs like Donanemab and Lecanemab?
New Alzheimer’s drugs such as donanemab and lecanemab are associated with several side effects, the most notable being amyloid-related imaging abnormalities (ARIA). These can include brain swelling (edema) and microhemorrhages, which may lead to severe complications. Patients undergoing treatment with these drugs should be closely monitored by healthcare professionals to manage and mitigate potential risks.
How effective are new Alzheimer’s drugs?
The effectiveness of new Alzheimer’s drugs like donanemab and lecanemab varies among patients. Clinical trials have shown that donanemab can reduce cognitive decline by 32% over 18 months, while lecanemab demonstrated a 27% reduction over the same period. While these results are promising, they indicate a slowing rather than a reversal of disease progression.
Are there any alternatives to new Alzheimer’s drugs?
Yes, there are alternatives to new Alzheimer’s drugs that focus on a holistic approach. Dr. Dale Bredesen advocates for a comprehensive treatment plan that includes dietary changes, physical exercise, cognitive training, sleep optimization, and targeted supplementation. This approach aims to address the multifactorial nature of Alzheimer’s disease and improve overall brain health.
What is the cost of new Alzheimer’s drugs?
The cost of new Alzheimer’s drugs can be quite high, often posing a financial burden on patients and their families. For example, lecanemab has been associated with substantial treatment costs, and insurance coverage may vary. It’s essential for patients to discuss financial options and support with their healthcare providers to manage the expenses associated with these treatments.
