Latest news with #lecanemab
Medscape
3 days ago
- Business
- Medscape
New Data: Wide Disparities in Access to Lecanemab
Access to lecanemab among Medicare beneficiaries with Alzheimer's disease (AD) or mild cognitive impairment (MCI) was marked by racial, ethnic, and socioeconomic disparities, a new study suggested, with early use significantly higher in men than in women, and in non-Hispanic White individuals than in Asian or Pacific Islander, Black, and Hispanic patients. METHODOLOGY: Researchers performed a cross-sectional analysis and examined early trends in lecanemab use among 842,192 US Medicare beneficiaries with at least 11 months of coverage. In all, 1725 Medicare beneficiaries who received at least one lecanemab infusion between 2023 and 2024 were identified (mean age at initiation, 75.7 years). The researchers identified beneficiaries with AD and MCI using claims in the previous year. The analysis included age, sex, race/ethnicity, urban-rural status, and socioeconomic status. TAKEAWAY: Of those who received lecanemab, 51.5% were women; 90.5% were White, 1.3% Asian or Pacific Islander, 1.2% Black, and 2% Hispanic individuals; 1.3% were socioeconomically disadvantaged; and 88% resided in urban areas. Among all patients with AD or MCI, lecanemab use was significantly higher in men than in women (0.27% vs 0.17%; P < .01), in urban residents than in rural patients (0.22% vs 0.14%; P < .01), and in socioeconomically advantaged patients than in those who were socioeconomically disadvantaged (0.27% vs 0.01%; P < .001). < .01), in urban residents than in rural patients (0.22% vs 0.14%; < .01), and in socioeconomically advantaged patients than in those who were socioeconomically disadvantaged (0.27% vs 0.01%; < .001). Lecanemab use was significantly higher among non-Hispanic White patients (0.23%) than among Asian or Pacific Islander (0.09%), Black (0.04%), and Hispanic (0.07%) patients ( P < .001 for all). < .001 for all). By the end of the study, 407 patients (23.6%) had discontinued lecanemab treatment, indicating substantial early discontinuation rates. IN PRACTICE: 'Even among beneficiaries who meet initial Medicare coverage requirements for lecanemab by having documented MCI or AD, early uptake of lecanemab still appears to be marked by racial, ethnic, and socioeconomic disparities. This dynamic is consistent with a recurring historical pattern of inequitable access to breakthrough therapies administered by specialized centers, and underscores how a costly and likely low-value treatment, which contributes to higher Medicare spending, is seemingly being disproportionately utilized by advantaged populations,' the study authors wrote. SOURCE: This study was led by Frank F. Zhou, David Geffen School of Medicine, University of California at Los Angeles (UCLA). It was published online on May 15 in JAMA Network Open . LIMITATIONS: Data for Medicare Advantage beneficiaries were not available. The use of diagnosis codes to identify patients with AD or MCI underestimated MCI prevalence, misdiagnosed AD, did not consider additional lecanemab eligibility criteria, and could not distinguish between mild and moderate or severe AD, where only mild cases are eligible for lecanemab treatment. DISCLOSURES: This study received funding from the National Institute on Aging, National Institutes of Health, US Deprescribing Research Network, UCLA Resource for Minority Aging Research/Center for Healthcare Improvement of Minority Elders, and National Center for Advancing Translational Sciences. Three investigators reported receiving grants from or having other ties with various sources. Details are provided in the original article.
Malay Mail
17-05-2025
- Health
- Malay Mail
US approves first blood test for Alzheimer's, enabling earlier diagnosis and treatment
WASHINGTON, May 17 — The United States yesterday approved the first blood test for Alzheimer's, a move that could help patients begin treatment earlier with newly approved drugs that slow the progression of the devastating neurological disease. The test, developed by Fujirebio Diagnostics, measures the ratio of two proteins in the blood. The rato is correlated with amyloid plaques in the brain—a hallmark of Alzheimer's that, until now, has been detected only through brain scans or spinal fluid analysis. 'Alzheimer's disease impacts too many people—more than breast cancer and prostate cancer combined,' said Food and Drug Administration Commissioner Marty Makary. 'Knowing that 10 percent of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.' There are currently two FDA approved treatments for Alzheimer's: lecanemab and donanemab, which target amyloid plaque and have been shown to modestly slow cognitive decline, though they do not cure the disease. Advocates for the intravenous antibody therapies, including many neurologists, say they can offer patients a few additional months of independence—and are likely to be more effective if started earlier in the disease's course. In clinical studies, the blood test produced results largely in line with positron emission tomography (PET) brain scans and spinal fluid analysis. 'Today's clearance is an important step for Alzheimer's diagnosis, making it easier and potentially more accessible for US patients earlier in the disease,' said Michelle Tarver of the FDA's Center for Devices and Radiological Health. The test is authorized for use in clinical settings for patients showing signs of cognitive decline, and results must be interpreted alongside other clinical information. Alzheimer's is the most common form of dementia. It worsens over time, gradually robbing people of their memories and independence. — AFP
Medscape
16-05-2025
- Health
- Medscape
New ‘Real World' Data on Lecanemab Side Effects
Patients with early Alzheimer's disease (AD) who initiated lecanemab treatment at a specialty memory clinic showed an expected and manageable side-effect profile, new research showed. 'The findings are very reassuring,' Barbara Joy Snider, MD, PhD, professor of neurology, and director of the Memory Diagnostic Center and Knight ADRC Clinical Trials Unit, Washington University School of Medicine, St. Louis, Missouri, told Medscape Medical News . 'We found similar rates of side effects in our patient population as were found in the phase 3 studies of lecanemab. Clinical trial volunteer participants tend to be very healthy, so it is not always a given that side effects will be similar in the clinical population, especially in older adults,' Snider explained. The study was published online on May 12 in JAMA Neurology. Real World Data Lecanemab was the first disease-modifying treatment for AD to receive traditional approval from the US Food and Drug Administration (FDA) in July 2023. However, side effects, including brain swelling and bleeding, which emerged during clinical trials, left some patients and clinicians hesitant to initiate treatment in appropriate patients. In this real-world analysis, Snider and colleagues took a look back at 234 patients with early symptomatic AD who initiated lecanemab infusions (10 mg/kg intravenous every 2 weeks) in the memory clinic at WashU Medicine over 14 months. Infusion-related reactions occurred in 87 (37%) study participants and were typically mild. During an average treatment period of 6.5 months, amyloid-related imaging abnormalities (ARIA) were observed in 42 of 194 patients (22%) who received at least four lecanemab infusions and underwent at least one monitoring MRI scan. Overall, 29 (15%) patients developed ARIA with edema/effusion, with or without ARIA with hemorrhage/hemosiderin deposition (ARIA-H) and 13 (6.7%) developed isolated ARIA-H. The majority of ARIA was asymptomatic and radiographically mild and most patients who developed ARIA stayed on treatment. Eleven patients (5.7%) developed symptomatic ARIA; only two patients (1.0%) had clinically severe ARIA. No deaths or microhemorrhages were observed. 'Importantly,' wrote the investigators, patients with mild dementia at baseline (Clinical Dementia Rating [CDR], 1) had a 15-fold higher rate of symptomatic ARIA than patients with mild cognitive impairment or very mild dementia (CDR, 0.5) at baseline (27% vs 1.8%, P < .001). 'We do not know for sure why people with very mild dementia had fewer side effects than people with mild dementia,' Snider told Medscape Medical News . 'Some findings published based on the clinical trials have shown that people with very mild dementia likely get more benefit from these medications, so this emphasizes the importance of diagnosing Alzheimer's disease when symptoms are very mild. We have a discussion with each patient and their family about the potential risks and benefits of these medications, so this will be part of that discussion,' Snider said. 'We need to gather more information and follow more patients, not only at our site but more broadly through efforts like ALZ-NET [Alzheimer's Network for Treatment and Diagnostics] to better understand what factors affect the risks and benefits of these medications,' Snider added. Summing up, Snider said this real-world analysis showed that 'recently approved antibodies against amyloid can be used in an outpatient clinical practice, side effects are as expected and can be managed, and only 1%-2% of patients had clinically concerning side effects.' 'Valuable' Evidence Commenting on this study for Medscape Medical News , Ozama Ismail, PhD, director of scientific programs at Alzheimer's Association, said the findings of this study 'support using approved amyloid-targeting treatments in clinical practice.' Ismail, who wasn't involved in the study, said this research contributes 'valuable evidence' about the side effects of lecanemab and their management and the findings 'align with what was seen during clinical trials.' 'That said, this is just one demonstration of how these treatments are being effectively implemented, administered, and managed within a regional population. Every clinic may have a different perspective and will be serving a different patient population,' Ismail cautioned. He noted that new FDA-approved treatments offer 'real hope for people living with early Alzheimer's, and they are redefining how Alzheimer's is addressed. Understanding how these therapies work in real-world settings is essential to improving treatment for everyone — this requires robust data collection beyond controlled clinical trials,' Ismail said. He also noted that Washington University Memory Diagnostic Center, where this work was done, is part of the ALZ-NET — a nationwide network where healthcare providers collect real-world data from patients who are being evaluated for treatment or are receiving treatment with new FDA-approved AD therapies. ALZ-NET now has more than 2000 patients enrolled in nearly 100 locations across the United States.
Medical News Today
16-05-2025
- Health
- Medical News Today
Alzheimer's: Real-world data shows lecanemab side effects are rare
The FDA approved lecanemab for Alzheimer's disease in 2023. Jakob Lagerstedt/Stocksy The medication lecanemab was approved by the U.S. FDA to treat Alzheimer's disease in 2023. Like all medications, lecanemab comes with the potential for side effects, including amyloid-related imaging abnormalities (ARIA), such as the presence of swelling or bleeding in the brain. The Clarity AD phase 3 clinical trial, published in 2022, reported very low percentages of participants experiencing ARIA. A new study reconfirms the Clarity AD findings by reporting that significant adverse events, such as ARIA, were rare and manageable in real-world use of lecanemab for people within the earliest stages of Alzheimer's disease. While there is currently no cure for a type of dementia called Alzheimer's disease, over the last few years, new medications have been introduced to help manage disease symptoms and slow its progression. Like all medications, lecanemab has the potential for side effects, including headaches, dizziness, muscle aches, and blurred vision, as well as a very serious side effect known as amyloid-related imaging abnormalities (ARIA), such as the presence of swelling or bleeding in the brain. In November 2022, scientists published the results of the Clarity AD phase 3 clinical trial aimed at determining the safety and efficacy of lecanemab in people with early Alzheimer's disease. In that study, researchers found 0.8% of participants experienced ARIA-E (edema/effusion) and 0.7% showed signs of ARIA-H (hemorrhage/hemosiderin deposition). Now, a new study recently published in JAMA Neurology reconfirms the Clarity AD findings by reporting that significant adverse events — such as ARIA — were rare and manageable in 'real-world' use of lecanemab for people with very mild or mild Alzheimer's disease. For this study, researchers recruited 234 people with early symptomatic Alzheimer's disease, with an average age of about 74, who received lecanemab at the outpatient specialty memory clinic, Washington University Memory Diagnostic Center. 'Lecanemab is an antibody, a kind of protein normally made in your body by your immune system,' 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 . 'Antibodies like lecanemab are designed to have specific targets and are manufactured, then administered to patients. Antibodies are used for many different conditions.' Lecanemab and amyloid proteins 'Lecanemab was designed to recognize certain types of amyloid protein . This is a protein that is made in your body and can become misfolded. When this happens, it can interfere with brain activity and can form clumps called amyloid plaques . This is what happens in Alzheimer's disease. Amyloid misfolding is not the only thing that happens in the brain in Alzheimer's disease, but it may be one of the first steps in the disease process that leads to memory loss and dementia.' — Barbara Joy Snider, MD, PhD 'In a large clinical trial, people who were treated with lecanemab for 18 months had about 25-30% less decline in their memory and thinking than did people who did not get the medication,' Snider said. 'It is important to note that the people treated with lecanemab did have a loss in their memory and thinking, so the drug did not reverse or completely stop the memory loss, but it did significantly slow it down. Imaging studies showed that the lecanemab also reduced and sometimes cleared the amyloid plaques in the brain,' she added. At the study's conclusion, researchers found that 1.8% of participants at the earliest stage of Alzheimer's disease showed symptoms of ARIA, compared to 27% of participants with mild Alzheimer's disease. 'This finding emphasizes the importance of early diagnosis. The clinical trial results showed that people with very mild symptoms likely benefit more from medications like lecanemab (40-50% slowing of decline instead of 25-30%), so people with very mild symptoms have more benefit and fewer side effects. This is also when it is hardest to be sure someone has Alzheimer's disease, so it is very important that we continue to work to improve access to diagnosis for people with very mild symptoms.' — Barbara Joy Snider, MD, PhD Snider and her team also discovered that of the 11 participants who experienced ARIA symptoms, the effects mostly disappeared within a few months, and no patients died. 'This is very similar to what was seen in the clinical trial,' Snider commented. 'This is very reassuring and tells us that these drugs can be used safely in a 'real world' clinic population.' 'We will continue to follow our patients and hope to learn more about side effects of these medications and about how much they slow down memory loss,' she continued. 'We look forward to sharing this information with other providers and to seeing larger studies through groups like Alz-Net. We are encouraged by our experience of providing amyloid-targeting treatments to appropriate patients and we look forward to the next generation of treatments for Alzheimer's disease.' MNT spoke with John Dickson, MD, PhD, a neurologist at Massachusetts General Hospital, about this study. Dickson commented that the study's findings are generally in line with what he has observed at his center. 'While ARIA does occur in patients treated with lecanemab, it has been manageable in our sub-specialty treatment program,' he explained. '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.' Lecanemab or donanemab? 'Further research to identify patients at increased risk for ARIA, especially serious ARIA with concerning symptoms or radiographic features, could help clinicians advise patients with more personalized recommendations regarding treatment based on individual patients' risk profiles. This may help patients make more informed decisions regarding their treatment options. These treatment decisions include whether or not to pursue treatment with anti-amyloid therapy, and if so, whether lecanemab or donanemab would be a better option.' — John Dickson, MD, PhD Dickson said that for future research, these findings should be examined in a larger patient sample and that the observation time should be extended. 'In general, the risk of ARIA is highest in the first six months of treatment,' he explained. 'While some of the patients included in this study had more than six months of treatment, some patients were observed for a shorter period of time. Thus, the results of this study may underestimate the number of patients who will develop ARIA from the study population.' 'While the approval of lecanemab offers a glimmer of hope for Alzheimer's patients, the potential for serious side effects makes it a complex decision for prescribing physicians,' Parulekar said. 'Careful patient selection, monitoring, and open communication about the benefits and risks are essential.' 'The benefit offered by lecanemab is a modest slowing of decline, not a cure or a dramatic reversal. It is important to weigh its benefit against the potential for serious side effects for each individual patient. This requires careful consideration of the patient's disease stage, overall health, and other risk factors.' — Manisha Parulekar, MD, FACP, AGSF, CMD 'Identifying patients who are most likely to benefit from lecanemab and least likely to experience serious side effects is crucial,' Parulekar added. 'Additional safety data and 'real world' experience [are] helpful for this process.' Alzheimer's / Dementia Clinical Trials / Drug Trials Seniors / Aging Drugs
Fox News
25-02-2025
- Health
- Fox News
Drugs that reduce dementia risk — and others that increase it
Some medications could have the unintended benefit of reducing dementia risk. That's according to a recent study by the universities of Cambridge and Exeter, where researchers evaluated several existing drugs to see if they could do double-duty as dementia treatments. The team reviewed data from 14 prior studies, which included more than 130 million patients and one million dementia cases, according to a press release. They determined that several classes of prescription drugs were shown to affect dementia risk. The findings were published in Alzheimer's and Dementia: Translational Research & Clinical Interventions. "We urgently need new treatments to slow the progress of dementia, if not to prevent it," said co-first author Dr. Ben Underwood, from the Department of Psychiatry at the University of Cambridge and Cambridgeshire and Peterborough NHS Foundation Trust, in the release. "If we can find drugs that are already licensed for other conditions, then we can get them into trials and — crucially — may be able to make them available to patients much, much faster than we could do for an entirely new drug." Antibiotics, antivirals, anticoagulants (blood thinners) and anticonvulsants (medications used to prevent or treat seizures) were all linked to a reduced risk of dementia, according to the study. Four vaccines — for hepatitis A, typhoid, hepatitis A and typhoid combined, and diphtheria — were also associated with a reduced risk. "This finding supports the hypothesis that common dementias may be triggered by viral or bacterial infections, and supports recent interest in vaccines, such as the BCG vaccine for tuberculosis, and decreased risk of dementia," the researchers wrote in the release. Anti-inflammatory medications, such as ibuprofen, were also found to reduce dementia risk. "Inflammation is increasingly being seen to be a significant contributor to a wide range of diseases, and its role in dementia is supported by the fact that some genes that increase the risk of dementia are part of inflammatory pathways," the release stated. Some drugs were associated with an increased risk of dementia, including antipsychotic medications. There was "conflicting evidence" for other classes of drugs, including those indicated for blood pressure, depression and diabetes. Two medications are currently approved for Alzheimer's treatment in the U.S. — lecanemab (Leqembi) and donanemab (Kisunla). Both are monoclonal antibodies that are administered via IV infusions. They work by reducing the build-up of amyloid plaques in the brain, but they are only effective for those with early-stage Alzheimer's and have the potential for some serious side effects, according to experts. "You should never change your medicine without first discussing it with your doctor." Dr. Chris Vercammen, a board-certified internal medicine physician at the University of California, San Francisco (UCSF), was not involved in the study but shared his reaction to the findings. "This review identifies classes of medications that have an association with an increased risk of dementia," Vercammen, who specializes in geriatrics and palliative care, told Fox News Digital. "Systematic reviews offer the advantage of aggregating data across multiple studies, which can provide a more comprehensive understanding of the current state of knowledge on a subject." The study did have some limitations, the researchers acknowledged, due to differences in how each individual study was conducted and how the data was gathered. Vercammen agreed that these types of reviews are limited by the overall quality of the available studies. "Furthermore, unlike meta-analyses, they do not provide a summary effect size for each medication, which makes it difficult to discuss risk precisely." Despite the limitations, Vercammen said the findings are "plausible" and highlight the importance of comprehensive medication reviews for older adults at risk of dementia. Lourida emphasized that all drugs have benefits and risks. "You should never change your medicine without first discussing it with your doctor, and you should speak to them if you have any concerns." Vercammen agrees that patients who are considering new medications or treatments should consult with their doctors. "Though dementia lacks a cure and available drugs present challenges, my experience highlights the value of personalized care," he told Fox News Digital. For more Health articles, visit "This involves addressing the practical needs of the person living with dementia and their caregivers — the 'second patients' — who provide essential daily support. This is the essence of continuous, compassionate care in the absence of a cure."
