Lecanemab's real-world usage indicates infrequent occurrence of adverse effects in Alzheimer's patients.
In the realm of Alzheimer's disease treatment, a groundbreaking medicine, lecanemab, took center stage when the US FDA approved it in 2023. Akin to a superhero in a science fiction novel, lecanemab, known commercially as Leqembi, charges forth to combat this dreadful type of dementia.
Like any superhero, lecanemab comes with its own set of challenges, as it too can take a toll on the body, causing side effects such as headaches, dizziness, muscle aches, and blurred vision. However, the most serious of these threats is amyloid-related imaging abnormalities (ARIA), which can manifest as swelling or bleeding in the brain.
The Clarity AD phase 3 clinical trial, a game-changer in the battleground of Alzheimer's, reported extraordinarily low percentages of participants experiencing ARIA in 2022. Fast forward to now, a brand-new study is out, reconfirming the Clarity AD findings by stating that significant adverse events, including ARIA, are uncommon and manageable in real-world use of lecanemab for individuals within the earliest stages of Alzheimer's.
The World's Latest Secret Weapon: Lecanemab
In this study, researchers enlisted the aid of 234 early-stage Alzheimer's patients, with an average age of roughly 74, who received lecanemab at an outpatient specialty memory clinic, Washington University Memory Diagnostic Center.
"Lecanemab is an immune system weapon, a type of protein usually produced within your body. These special proteins, much like lecanemab, are designed to have specific targets and are synthesized, then administered to patients. They have applications for treating a multitude of conditions." – Barbara Joy Snider, MD, PhD, a professor of neurology at WashU Medicine and affiliated with the Knight Alzheimer's Disease Research Center, and co-senior author of this study, explained to Medical News Today.
In the conflict against Alzheimer's, lecanemab and amyloid proteins are inexorable adversaries, as the disease arises from misfolded amyloid proteins that disrupt brain activity and form detrimental clumps called plaques.
"Lecanemab was created to recognize these specific types of . This destructive protein might be the first step in the disease process that leads to memory loss and dementia." - Barbara Joy Snider, MD, PhD
In the grand, 18-month clinical trial, participants who were treated with lecanemab experienced roughly 25-30% less decline in their memory and thinking abilities compared to those who did not receive the medication.
"It is important to note that the persons treated with lecanemab still showed a decline in their memory and thinking, so the medication did not reverse or completely halt the memory loss, but it did significantly slow it down. Imaging studies revealed that the lecanemab also decreased and, at times, eliminated the amyloid plaques in the brain." - Barbara Joy Snider, MD, PhD
In the study's conclusion, researchers discovered that 1.8% of participants at the earliest stage of Alzheimer's disease demonstrated ARIA symptoms, contrasted with 27% of those with mild Alzheimer's disease.
Snider and her team also realized that the effects of ARIA, for most of the 11 participants who experienced it, subsided within a few months, with no fatalities reported.
"This finding underscores the significance of early diagnosis. The clinical trial results showed that individuals with very mild symptoms are likely to gain more benefits from medications like lecanemab (forty to fifty percent slowing in decline as opposed to twenty-five to thirty percent), so these individuals stand to reap greater benefits and fewer side effects. This is also the stage at which it is hardest to ascertain whether someone has Alzheimer's, so it is crucial that we continue to work on improving access to diagnosis for individuals with very mild symptoms." – Barbara Joy Snider, MD, PhD
Snider and her colleagues will continue to follow their patients, hoping to uncover more insights regarding lecanemab's side effects and its impact on memory loss. They eagerly await the opportunity to share their findings with other providers and to witness larger studies, such as those conducted by groups like Alz-Net, in order to advance the fight against Alzheimer's disease.
Future Research for Superior Understanding
John Dickson, MD, PhD, a neurologist at Massachusetts General Hospital, spoke with MNT about this study. Dickson offered insights, stating that the study's findings align with his observations in his center.
"While ARIA does occur in patients treated with lecanemab, it tends to be manageable within our sub-specialty treatment program. The risk of ARIA is often the most significant consideration in eligible patients' decisions about whether to pursue treatment with anti-amyloid therapy or not." – John Dickson, MD, PhD
Dickson continued, "Further research to identify patients at an increased risk for ARIA, particularly those with concerning symptoms or radiographic features, could help clinicians offer more personalized guidance to patients regarding their treatment options. This may aid patients in making more informed choices regarding whether or not to pursue treatment with anti-amyloid therapy and, if so, whether lecanemab or donanemab would be the superior option." – John Dickson, MD, PhD
In discussing future research, Dickson suggested that these findings should be examined across a larger patient population and that the observation period should be extended. "In general, the risk of ARIA is highest in the first six months of treatment. While some of the participants included in this study had more than six months of treatment, some patients were observed for a shorter duration, possibly resulting in an underestimation of the number of patients who will develop ARIA from the study population." – John Dickson, MD, PhD
Weighing Benefits and Side Effects for Lecanemab
Manisha Parulekar, MD, FACP, AGSF, CMD, Director of the Division of Geriatrics at Hackensack University Medical Center in New Jersey, spoke with MNT about this research. Parulekar stated, "While the approval of lecanemab offers a glimmer of hope for Alzheimer's patients, the potential for serious side effects necessitates careful thought when prescribing this medication. Judicious patient selection, monitoring, and open communication about the benefits and risks are essential."
Parulekar further explained that the benefit provided by lecanemab is a modest slowing of decline, not a cure or a dramatic reversal of symptoms. "It is imperative to weigh the benefit against the potential for severe side effects on an individual basis. This calls for a closer examination of the patient's disease stage, overall health, and other risk factors." – Manisha Parulekar, MD, FACP, AGSF, CMD
Parulekar also emphasized, "Identifying patients who are most likely to benefit from lecanemab and least likely to experience serious side effects is crucial. Additional safety data and 'real-world' experience will aid this process."
- In the realm of Alzheimer's disease treatment, lecanemab, a groundbreaking medicine, was approved by the US FDA in 2023, acting as a superhero in the fight against this devastating form of dementia.
- Like any superhero, lecanemab comes with its own set of challenges, causing side effects such as headaches, dizziness, muscle aches, and blurred vision, but it is especially important to be aware of the risk of amyloid-related imaging abnormalities (ARIA), which can manifest as swelling or bleeding in the brain.
- A recent study involving 234 early-stage Alzheimer's patients reported statistically low percentages of participants experiencing ARIA symptoms when using lecanemab, reconfirming findings from the Clarity AD phase 3 clinical trial.
- Lecanemab is an immune system weapon, much like proteins naturally produced within the body, designed to target specific conditions, including Alzheimer's disease, which is caused by misfolded amyloid proteins that disrupt brain activity and form detrimental clumps called plaques.
- In the study, participants who were treated with lecanemab experienced approximately 25-30% less decline in their memory and thinking abilities compared to those who did not receive the medication, and imaging studies revealed that lecanemab also decreased and eliminated amyloid plaques in the brain.
- Future research should focus on identifying patients at an increased risk for ARIA, particularly those with concerning symptoms or radiographic features, as this will help clinicians offer more personalized guidance to patients regarding their treatment options.
- While the approval of lecanemab offers hope for Alzheimer's patients, it is essential to weigh the benefit against the potential for serious side effects on an individual basis, taking into account the patient's disease stage, overall health, and other risk factors, as well as monitoring patients closely to assess the impact on memory loss and side effects.
