In a potential breakthrough, two novel Alzheimer’s drugs are showcasing encouraging outcomes in slowing down the progression of the disease during its early stages.
Recent research has unveiled promising results about the effectiveness of a fresh Eli Lilly medication, known as Donanemab, in curbing the advancement of Alzheimer’s by approximately 35%.
For individuals in the initial phases of the disease, Donanemab exhibited the ability to decelerate memory decline and cognitive deterioration by an estimated range of 4.5 to 7.5 months over an 18-month span when compared to those administered with a placebo.
Furthermore, the extent of the deceleration appeared most pronounced among patients in the early disease stage who exhibited lower levels of tau—a protein responsible for the formation of brain “tangles.”
These findings, unveiled at the Alzheimer’s Association International Conference in Amsterdam, suggest that donanemab’s efficacy is at least on par with another Eli Lilly drug, Leqembi, which displayed a 27% reduction in the progression of Alzheimer’s.
While Leqembi received FDA approval in January and discussions regarding its accessibility have commenced, Donanemab is currently undergoing FDA evaluation.
Evolving Treatment Landscape
It is essential to recognize that these medications are not curative solutions for Alzheimer’s. However, they present a significant stride in the right direction by slowing disease progression, which could provide patients with extended periods of independent living.
Dr. Christopher Scuderi, Medical Director for Value-Based Care at Northeast Florida Millennium Physician Group, emphasized that “These drugs are not a cure for Alzheimer’s. They help slow down progression for patients with early disease which is a large positive step and can help patients live independently longer.”
Comparing Leqembi and Donanemab
Both Leqembi and Donanemab, administered through intravenous infusions, stand as the pioneering drugs with documented evidence of mitigating cognitive decline in Alzheimer’s patients.
Their mechanism involves targeting amyloid, a protein present in the human brain. Excessive amyloid can lead to protein aggregation, forming plaques that contribute to Alzheimer’s disease.
However, both drugs have been associated with serious side effects, notably brain swelling and bleeding. The Donanemab trial reported higher rates of these side effects compared to the Leqembi trial. Additionally, neither drug has the capacity to reverse or repair brain damage already caused by Alzheimer’s.
Addressing Representation and Safety
A critical concern in the development of these drugs is the inadequate representation of affected communities in clinical trials. The Alzheimer’s Association expressed disappointment over the limited progress in improving diversity within Alzheimer’s clinical trials.
Dr. Nicole Purcell, Alzheimer’s Association Senior Director of Clinical Practice, highlighted the need for trials to accurately reflect the population they aim to serve, as dementia disproportionately affects certain communities.
Despite the potential for serious side effects, experts remain optimistic about the positive transformation these drugs could bring to Alzheimer’s patients’ lives.
The Way Forward and Accessibility
As the drugs attain approval, it’s essential to consider the specific populations for which they are sanctioned. Leqembi, granted traditional FDA approval, targets patients with mild cognitive impairment (MCI). The therapies have not yet been evaluated in patients with advanced Alzheimer’s.
Accurate early diagnosis becomes pivotal in determining the eligibility of individuals for these treatments.
While a relatively small percentage of early-stage Alzheimer’s patients qualify for these drugs due to specific trial criteria, experts unanimously call for continued research to enhance accessibility and treatment effectiveness for patients at various stages of the disease.
Dr. Purcell envisions a future where early diagnosis and treatment facilitate a comprehensive approach, integrating lifestyle changes, caregiving, and future planning to assist Alzheimer’s patients in leading fulfilling lives.
In this evolving landscape, the approval of these drugs introduces newfound hope. Dr. Scuderi aptly summarized the sentiment: “What these drugs offer is hope… As we start to see early success in treatment, this opens the door to further research that will hopefully lead to more impactful treatment in the future.”