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Last update 08 Feb 2025

Lecanemab

Last update 08 Feb 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-amyloid beta protofibril antibody, Immunoglobulin G1, anti-(human beta-amyloid protofibril) (human-mus musculus monoclonal BAN2401 heavy chain), disulfide with human-mus musculus monoclonal BAN2401 light chain, dimer, lecanemab-irmb

+ [7]

Target

APP

Mechanism

APP inhibitors(Beta amyloid A4 protein inhibitors)

Therapeutic Areas

Nervous System DiseasesCongenital DisordersOther Diseases

Active Indication

Dementia due to Alzheimer's disease (disorder)Mild cognitive disorderAlzheimer Disease+ [2]

Inactive Indication-

Originator Organization

Active Organization

+ [4]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (06 Jan 2023),

Alzheimer Disease

RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Priority Review (CN), Innovative Licensing and Access Pathway (GB), Priority Review (JP)

Structure/Sequence

Sequence Code 315606586L

Source: *****

Sequence Code 315606587H

Source: *****

Clinical Trials associated with Lecanemab

NCT05999084

/ RecruitingNot ApplicableIIT

Georgia Memory Net Center for Medicare and Medicaid Services Registry for Anti-Amyloid Monoclonal Antibody Coverage with Evidence Development

The purpose of this registry is to compile information on patients who are receiving FDA-approved anti-amyloid mAbs in the course of their clinic visits in the Emory Cognitive Neurology Clinic and in Georgia Memory Net Memory Assessment Clinics.

Start Date01 Nov 2024

Sponsor / Collaborator

Emory University

[+1]

NCT06602258

/ RecruitingPhase 2

A Phase 2, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Study to Evaluate Safety, Tolerability, and Biomarker Efficacy of E2814 With Concurrent Lecanemab Treatment in Subjects With Early Alzheimer's Disease

The primary objective of the study is to determine the dose response of E2814, when concurrently administered with lecanemab, on the change from baseline at 6 months in cerebrospinal fluid (CSF) microtubule-binding region (MTBR)-tau-243 in participants with early Alzheimer's disease (AD).

Start Date30 Sep 2024

Sponsor / Collaborator

Eisai, Inc.

NCT06741553

/ RecruitingNot ApplicableIIT

A Study That Uses an Organized System to Prospectively Collect Uniform Data from a Defined Population

As the population increases and aging intensifies, cognitive disorders represented by Alzheimer's disease (AD) not only pose a severe threat to public health but also bring significant social and economic burdens. Previously, treatment options for Alzheimer's disease were very limited, mainly providing symptomatic relief with few available medications. Lecanemab, an FDA-approved clinical treatment drug in 2023, targets the core pathology of AD-abnormal amyloid-beta (Aβ) aggregation in the brain-and has been validated through both biomarker and clinical scale assessments. The optimal dosage and safety-efficacy profile of lecanemab for treating early AD have been observed in phase 2 and phase 3 clinical trials. However, the use of lecanemab may lead to certain adverse effects, including infusion-related reactions, amyloid-related imaging abnormalities (ARIA), such as microhemorrhages or hemosiderin deposits (ARIA-H), and ARIA-E. This study aims to establish a prospective follow-up cohort of patients treated with lecanemab to observe changes in cranial imaging characteristics and clinical symptoms, assess the cognitive improvement effects of lecanemab in early AD patients (stages 3-4), and monitor the risk factors for adverse event occurrence.

Start Date01 Aug 2024

Sponsor / Collaborator

Second Affiliated Hospital Zhejiang University College of

100 Clinical Results associated with Lecanemab

100 Translational Medicine associated with Lecanemab

100 Patents (Medical) associated with Lecanemab

367

Literatures (Medical) associated with Lecanemab

01 Apr 2025·JOURNAL OF AFFECTIVE DISORDERS

Characteristics of adverse events and clinical risks of Lecanemab based on FAERS data

Article

Author: Zhu, Haohao ; Lu, Rongrong ; Gu, Jun ; Du, Zhiqiang ; Jiang, Ying ; Li, Zhaohui

OBJECTIVE:

This study aims to analyze the distribution of adverse events (AEs) related to Lecanemab in real-world settings based on FAERS database data.

METHODS:

Using the FAERS database, AE data related to Lecanemab was collected from Q3 2023 to Q2 2024. Signal mining was conducted using frequency and Bayesian methods to identify positive signals associated with Lecanemab.

RESULTS:

A total of 8,284,874 AE reports were collected, with 894 related to Lecanemab. Signal mining identified 22 SOCs, involving 46 PTs. Nervous system disorders had the highest report count, with Amyloid-Related Imaging Abnormalities (ARIA) being the most prominent AE, with high report numbers and signal strength, manifesting as brain edema, microhemorrhages, and iron deposits in the brain. Additionally, infusion-related reactions were common, including headache, chills, and fever. The study also revealed some new potential AEs, such as anger, cognitive disorder, disorientation, and abnormal dreams. Although these psychiatric symptoms had a lower report count, their high signal strength suggests that Lecanemab may impact patients' mental states. Rare but severe AEs, such as encephalitis, pancreatic carcinoma, and subdural hematoma, had low report numbers but high signal strength, highlighting potential risks for these severe events, especially in high-risk patients with relevant medical histories.

CONCLUSION:

This study unveils certain potential risks associated with Lecanemab in real-world applications. Further clinical studies are needed to validate these findings and provide guidance for safe medication practices.

05 Feb 2025·ACS Chemical Neuroscience

The Missing Link in Antiamyloid Therapy

Article

Author: Guha Roy, Rimil ; Patira, Riddhi ; Sindhu, Brahmdeep ; Gogniat, Marissa A. ; Mandal, Pravat K ; Maroon, Joseph C.

Alzheimer's disease (AD) impacts millions of elderly adults worldwide causing cognitive decline and severe deterioration of activities of daily life. The popular causal hypotheses for several decades include beta-amyloid (Aβ) deposition and tau hyperphosphorylation. AD research and more than 34% of clinical trials in AD are based on these two hypotheses. A phase-III clinical trial of lecanemab in early AD and mild cognitive impaired (MCI) patients reported a delay in cognitive decline of 27% over an 18-month treatment schedule. This multicenter trial found high specificity of lecanemab toward toxic protofibrils and subsequent clearance of beta-amyloid. There were, however, adverse events, which included cerebral edema and intracerebral hemorrhages in 23.1% of patients compared to 9.3% for those who received a placebo. Suboptimal clinical outcomes, brain volume loss, and adverse events in lecanemab treatment prompted a search for an alternative etiopathogenic explanation. Our research and others have focused on the oxidative stress (OS) hypothesis in AD. Autopsy studies have found significant depletion of the master antioxidant glutathione (GSH) in the hippocampal region, and is believed to be an early event in AD progression. Hippocampal GSH depletion is positively correlated with memory impairment. We have confirmed non-invasively with magnetic resonance spectroscopy (MRS) the depletion of GSH in patients with MCI and AD. We therefore propose a combinational therapy involving oral supplementation of gamma-glutamylcysteine (GGC), an early precursor of glutathione, to replenish brain GSH in addition to lecanemab, potentially to maximize desirable outcomes from combined therapeutic approach.

01 Feb 2025·AGEING RESEARCH REVIEWS

Monoclonal therapy with lecanemab in the treatment of mild Alzheimer's disease: A systematic review and meta-analysis

Review

Author: Vergara-Cadavid, Guillermo ; Castro-Leones, Maryarena ; Arroyo-Pacheco, Nelson ; Sarmiento-Blanco, Shayury ; Contreras-Puentes, Neyder

Alzheimer's disease, a progressive neurodegenerative pathology, is characterized by the accumulation of Amyloid-β plaques in the brain. Lecanemab (BAN2401), a humanized IgG1 monoclonal antibody, binds with high affinity to Amyloid-β protofibrils. It is the first monoclonal antibody for Alzheimer's disease to receive full FDA approval. This systematic review, conducted meticulously, examines the current use and safety of Lecanemab in treating Alzheimer's disease. We screened literature from databases such as PubMed Central, PubMed (MedLine), ScienceDirect, Scopus, Web of Science, and Wolters Kluwer for randomized controlled trials testing Lecanemab for cognitive decline in patients with mild cognitive impairment due to Alzheimer's disease. Outcomes measured included CDR-SB, ADCOMS, ADAS-Cog, and Amyloid burden on PET in centiloids. Likewise, reports were analyzed for adverse events associated with ARIA-A and ARIA-H. Five papers were included in the systematic review and three in the meta-analysis. The meta-analysis showed that Lecanemab slowed the progression of cognitive impairment as measured by CDR-SB, ADCOMS, and ADASCog, and significantly reduced Amyloid burden on PET in centiloids. However, Lecanemab was associated with an increased risk of ARIA-E and ARIA-H. Lecanemab has demonstrated efficacy in slowing cognitive impairment progression in Alzheimer's disease as measured by ADCOMS, ADAS-Cog, and CDR-SB. However, it is associated with an increased risk of ARIA-E and ARIA-H, particularly in ApoE4 carriers.

975

News (Medical) associated with Lecanemab

07 Feb 2025

·www.prnewswire.com

January Recap: 13 Top Health Press Releases

A roundup of the most newsworthy healthcare press releases from PR Newswire, including Zimmer Biomet's acquisition of Paragon 28, Icy Hot's partnership with Unrivaled and three major health news trends from January. NEW YORK, Feb. 7, 2025 /PRNewswire/ -- With thousands of press releases published each month, it can be difficult to keep up with everything on PR Newswire. To help healthcare journalists and consumers stay on top of the month's most popular releases and newsworthy trends, here's a recap of some of the past month's most read- and engaged-with stories. The list below includes the headline (with a link to the full text) and an excerpt from each story. Click on the press release headlines to access accompanying multimedia assets that are available for download. Continue Reading PR Newswire Monthly Health Press Release Roundup, January 2025. Photos provided by Icy Hot, March of Dimes Inc. and BD (Becton, Dickinson and Company). Zimmer Biomet Announces Definitive Agreement to Acquire Paragon 28 "This proposed transaction further diversifies Zimmer Biomet's portfolio outside of core orthopedics and positions us well in one of the highest growth specialized segments in musculoskeletal care…," said Ivan Tornos, President and Chief Executive Officer of Zimmer Biomet. Icy Hot Signs on as Official Recovery Partner of Unrivaled Icy Hot will serve as the Official Recovery Partner of the groundbreaking professional women's basketball league. Icy Hot will provide topical pain relief products to players during games and practice sessions, and in recovery and training facilities throughout the nine-week season. AbbVie and Neomorph Announce Collaboration to Develop Molecular Glue Degraders for Oncology and Immunology "We are excited to collaborate with Neomorph to develop novel molecular glue degraders which could pave the way for new, effective therapies in the treatment of immune disorders and cancer," said Steven Elmore, vice president, small molecule therapeutics and platform technologies at AbbVie. Michael J. Fox Honored with Presidential Medal of Freedom The nation's highest civilian honor recognizes his tireless advocacy and dedication to speeding a cure for Parkinson's disease. "I'm grateful for this recognition, which I share with the patients, families and researchers who have brought us closer than ever to ending Parkinson's disease once and for all," said Fox. Ginkgo Bioworks Partners with Universal Cells, an Astellas Company, to Advance Next-Generation iPSC-Derived Cell Therapies for Solid Tumors iPSC-derived cell therapies have the potential to transform cancer care by offering scalable, 'off-the-shelf' treatment options. The companies aim to accelerate the development of more potent and durable cell therapies while maintaining manufacturability at scale. Eirion Therapeutics Announces Potential Breakthrough Treatment for Hair Loss Based on First-in-Man Clinical Trial Results "We believe that ET-02 has the potential to not only treat but prevent androgenic alopecia. The results of this clinical trial show we are an important step closer to potentially having a solution for hair loss," said Jon Edelson, MD, CEO and President of Eirion. Variant Bio Announces Multi-Year Research Partnership with Novo Nordisk to Discover Novel Targets for Metabolic Disease "Metabolic disease - including obesity - affects people all over the world, yet newer targets with genetic evidence are primarily based on studies with European-ancestry populations. As a result, there is still an unmet need in this space," said David Moller, Chief Scientific Officer at Variant Bio. Panasonic Well Sets the Stage for the Future of Family Wellness in Opening Keynote at CES 2025 Families are at their breaking point as chronic stress, disconnection, and fragmented wellness solutions are taking a toll, and the call for help is loud and clear. To confront the mounting wellness imperatives families face in their daily lives, Panasonic Well CEO Yoky Matsuoka, took the stage to introduce the next step in building a comprehensive wellness ecosystem to support families. SPRAVATO® (esketamine) approved in the U.S. as the first and only monotherapy for adults with treatment-resistant depression This approval, which was granted following FDA Priority Review, is supported by positive results from the randomized, double-blind, multicenter, placebo-controlled study in which SPRAVATO® alone showed a rapid and superior improvement in depressive symptoms compared to placebo as early as 24 hours. GORTEC Announces New Trial Success for Head and Neck Cancer Treatment "This is the first time in decades where a therapy demonstrated superiority over standard of care cisplatin-radiotherapy in high-risk patients with [locally advanced squamous cell carcinoma of head and neck] LA-SCCHN," said Prof Jean Bourhis, Principal Investigator of the study and Medical Director of the GORTEC. Viking Therapeutics Announces Initiation of Phase 2 VENTURE-Oral Dosing Trial of VK2735 Tablet Formulation in Patients with Obesity Company announced the initiation of a 13-week study to evaluate the safety and efficacy of oral VK2735 dosed once daily. VK2375 is being developed in both oral and subcutaneous formulations for the potential treatment of various metabolic disorders such as obesity. Boston Scientific Announces Agreement to Acquire Bolt Medical, Inc. The acquisition is expected to further Boston Scientific's strategy to address coronary and peripheral disease. "Bolt Medical is developing a next-generation technology that is highly complementary to our existing portfolio. The addition of this system to our offerings can help us better serve physicians and their patients," said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Ongoing treatment can slow disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer. For maintenance treatment, once every four weeks dosing regimen may be easier than once every two weeks dosing for patients and care partners to continue treatment for early Alzheimer's Disease. For more news like this, check out all of the latest health-related releases from PR Newswire. Do you have a health press release to distribute? Sign up with PR Newswire to share your story with the audiences who matter most. Trending Topics Among the health news that was distributed in January, the PR Newswire team was able to spot several larger stories that highlight the trends shaping the industry. Cervical Cancer Awareness Month: January saw an increased focus on women's health, with our team noting a surge in new medical guidelines and concerning research findings. The American Cancer Society released data showing cancer mortality continues to decline despite rising incidence in women. New ASCCP guidelines introduced more precise screening methods, while survey results revealed many women are skipping critical OB-GYN exams - highlighting ongoing challenges in cervical cancer prevention and detection. Maternal Health Awareness Day: The maternal health crisis generated significant wire activity surrounding Maternal Health Awareness Day, which was observed on Jan. 23. March of Dimes celebrated historical White House engagement on the issue and healthcare providers shared promising results from innovative programs, including MedStar Health's Safe Babies Safe Moms initiative and Preeclampsia Foundation's creative intervention targeting Black maternal health. California Wildfires Response: As wildfires devastated the Los Angeles area, PR Newswire distributed a wave of announcements as organizations across sectors mobilized support for affected communities. Healthcare providers like CVS Health, DaVita and Magellan Health ensured continued care and crisis support. Fitness chains including 24 Hour Fitness and Crunch opened their facilities to displaced residents. Specialized assistance came from organizations like Braille Institute supporting visually impaired individuals, while companies donated air purifiers and other relief supplies to vulnerable populations. All news releases related to severe storms and extreme weather events across the U.S. can be found here. Looking ahead: PR Newswire anticipates significant wire activity in February around American Heart Month, with releases spotlighting cardiovascular health innovations and awareness campaigns. Early February announcements are expected to focus on cancer research breakthroughs around World Cancer Day (Feb. 4), while health equity themes will likely dominate coverage of National Black HIV/AIDS Awareness Day (Feb. 7). Helping Journalists Stay Up to Date on Industry News These are just a few of the recent press releases that consumers and the media should know about. To be notified of releases relevant to their coverage area, journalists can set up a custom newsfeed with PR Newswire for Journalists. Once they're signed up, reporters, bloggers, and freelancers have access to the following free features: Customization: Users can create customized newsfeeds that will deliver relevant news right to their inbox. Newsfeed results can be targeted by keywords, industry, subject, geography, and more. Photos and Videos: Thousands of multimedia assets are available to download and include in a journalist or blogger's next story. Subject Matter Experts: Journalists will have access to ProfNet, a database of industry experts to connect with as sources or for quotes in their articles. Related Resources: Our journalist- and blogger-focused blog, Beyond Bylines, features regular media news roundups, writing tips, upcoming events, and more. About PR Newswire PR Newswire is the industry's leading press release distribution partner with an unparalleled global reach of more than 440,000 newsrooms, websites, direct feeds, journalists and influencers and is available in more than 170 countries and 40 languages. From our award-winning Content Services offerings, integrated media newsroom and microsite products, Investor Relations suite of services, paid placement and social sharing tools, PR Newswire has a comprehensive catalog of solutions to solve the modern-day challenges PR and communications teams face. For 70 years, PR Newswire has been the preferred destination for brands to share their most important news stories across the world. For questions, contact the team at [email protected]. SOURCE PR Newswire WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalClinical ResultAcquisitionPhase 2

04 Feb 2025

·endpts.com

New study will try to stop Alzheimer’s decades before it begins, using experimental Eli Lilly drug

Alzheimer’s disease has afflicted Hannah Richardson’s family for generations. A rare genetic mutation, passed down from her great-grandmother, has struck her relatives with the first signs of memory loss at an average age of 39. Last year, her uncle died with dementia at 42. Her mother, now the same age, is in the moderate stages of the disease. Richardson, 24, has joined a clinical trial hoping to avoid the same fate. She will be one of the youngest people ever to receive an experimental drug intended to prevent dementia-linked amyloid plaques from building up in the first place. “I knew immediately I wanted to be a part of it,” she told Endpoints News in an interview. The study, helmed by Washington University School of Medicine in St. Louis, will enroll people who carry genes for inherited forms of Alzheimer’s, but who aren’t expected to develop their first symptoms for another 11 to 25 years. “Amyloid pathology can be identified one to two decades before people develop symptoms,” Eric McDade, a professor of neurology who is leading the study, told Endpoints. “What we’re trying to do is actually show that we can prevent that amyloid pathology from developing.” They’ll use an experimental Eli Lilly drug called remternetug. It is similar to the Indianapolis drugmaker’s drug Kisunla, which was approved last summer, but is administered as a quarterly injection instead of a monthly infusion. The trial is expected to last at least six years and cost more than $130 million. Most of the funding, an estimated $98.3 million, will come from the National Institutes of Health. If successful, it could provide one of the most dramatic tests yet of the much-debated amyloid hypothesis. “This is really going to be a landmark study,” Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation, told Endpoints. “I believe it is the earliest treatment trial that has ever been conducted.” For years, drugmakers failed to make a dent in Alzheimer’s, either because they went after the wrong form of amyloid or tested the drugs in patients too deep in the throes of the disease. Two approved drugs, Eisai and Biogen’s Leqembi and Lilly’s Kisunla, are marketed for mild cognitive impairment, the earliest symptomatic stage of Alzheimer’s where brainpower noticeably begins to fade. But the effects are modest, and the companies have now started identifying patients with blood tests and brain scans, but no outward signs of memory loss, to start treatment earlier. Those tests are now underway. Results from Lilly’s trial could come as soon as 2027, and Eisai’s study is scheduled to start wrapping up in 2028. But the WashU Medicine study aims to treat people even earlier, before there’s almost any progression of the disease in the brain. It’s a bet that they might be able to prevent, not just slow, the disease. “Most of the people that will start this study won’t have any amyloid in their brain that we can detect,” McDade said. “We’re calling it primary prevention.” Fillit compared the approach to using statins in young people with high cholesterol before they develop coronary artery disease. “Except these are people that don’t even have the biomarker evidence,” he added. Last week, Richardson went in to get her blood and spinal fluid collected and her brain scanned. The tests will provide a baseline for doctors to track her progress in the years to come. “I’ve been aware of Alzheimer’s in my family since a young age, so I’ve had a long time to kind of sit with that,” Richardson said. “But now, being the one going through the tests and the imaging and receiving the first dose of the medication in a few weeks, it definitely is eye-opening.” The study is part of the Dominantly Inherited Alzheimer Network Trials Unit, or DIAN-TU, a closely-watched effort at WashU Medicine to investigate drugs in people with rare mutations who are almost guaranteed to develop the disease. Richardson’s mom and uncle participated in another DIAN-TU study when they were in their early 30s. Most people in the study already had amyloid plaques by the time they got an experimental Roche drug called gantenerumab. Although the drug seemed to lower amyloid, it didn’t slow cognitive decline. McDade, the trial leader, originally planned to use gantenerumab again in a primary prevention study, but after it failed in Roche’s own trials in 2022, he looked for another option. He landed on remternetug, which seemed like a simpler alternative to Leqembi, infused every two weeks, and Kisunla, infused every month. “If we really, truly have to treat people for a decade or more, you certainly don’t want them coming in for infusions every two weeks,” McDade said. Richardson and about 240 other participants in the study will get an injection of remternetug or a placebo every three months for two years. “What we can’t do, kind of ethically and realistically, is run a placebo-controlled trial for 20 years,” McDade said. As a comparison, the study will include family members who don’t carry the Alzheimer’s risk genes. Measuring amyloid on brain scans is the primary outcome. After the initial two years, people with the mutations can continue to get injections of the drug in an open-label extension for another four years. Beyond that, McDade expects that people will need less frequent dosing, but the details of how often that will be are to be determined. Richardson is clear-eyed about her family’s medical history. “I hope there is benefit,” she said. “But even if that is not the outcome, just collecting this data is still so important for helping people down the line not suffer the way that people are suffering now, and that’s really important to me.”

Clinical Study

31 Jan 2025

·www.businesswire.com

Study Highlights How C2N’s PrecivityAD2™ Blood Biomarker Test Use Improves Clinical Decision-Making in the Evaluation for Alzheimer’s Disease

ST. LOUIS--( BUSINESS WIRE )--Researchers have determined that healthcare providers increased their ability to make Alzheimer’s disease (AD) probability judgments on their patients when they used the PrecivityAD2™ blood biomarker (BBM) tests from C2N Diagnostics, LLC , which aid them in the detection of amyloid plaques in the brain, a pathological hallmark of AD. This change in clinician-reported probability of AD is also associated with meaningful improvements in downstream clinical care, including changes in plans for AD medications as well as additional brain amyloid testing. This research, Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study, was published in the peer-reviewed Diagnostics journal . The research found: With the PrecivityAD2 blood test, clinicians’ diagnostic confidence in AD rose from approximately 50-60% to over 90% among patients with a positive Amyloid Probability Score 2 (APS2) result, guiding management decisions. Patients with a positive APS2 result (which would be consistent with an AD diagnosis) had a 35% increase in AD medication prescribing as well as increased use of disease-modifying therapy lecanemab. Patients with a negative APS2 (which would be inconsistent with an AD diagnosis) had an over 70% reduction in AD medication prescribing and additional brain amyloid testing. Clinicians prescribed the blood test in high accordance with its intended use criteria. The QUIP II study (NCT06025877) involved eight academic and community-based practice sites, and 12 memory specialists who treated a total of 203 patients presenting with AD symptoms or other causes of cognitive decline. It included a final analysis cohort of 28% patients that were identified by the clinician as typically under-represented Black, Hispanic and Asian minorities; they had a median age of 74 and over half (53%) were female. The memory specialists received education and training on the intended use of this BBM test as well as the APS2 result, which combines the plasma Aβ42/Aβ40 ratio and the ptau217/np-tau217 ratio (%p-tau217) measurements in a statistical algorithm to yield the score that informs on the likelihood of brain amyloid plaques. Each clinician then completed a survey that was built within a HIPAA (Health Insurance Portability and Accountability Act) compliant survey system. The survey collected clinician feedback concerning pre- and post-BBM test diagnostic certainty, as well as pre- and post-BBM test patient management plans, including medication prescribing and additional brain amyloid evaluation. Dr. Robert M. Carlile, one of the study investigators based at Palmetto Primary Care Physicians in Summerville, S.C., says, “Patients and families have greatly benefited from healthcare providers having access to C2N’s PrecivityAD2 blood test to help diagnose Alzheimer’s disease. The test was straightforward to incorporate into my clinical practice. The overall outcome has been clinically meaningful changes in decision-making around AD diagnostic certainty, drug therapy management and additional brain amyloid evaluation among patients evaluated for cognitive impairment. This all increases our ability to develop diagnostic certainty and impact clinical management in patients.” Dr. Joel Braunstein, CEO of C2N Diagnostics, says, “This research increases the growing body of evidence that demonstrates high clinical utility with blood biomarkers, which is bringing important advancements to the field. Too often, patients face a complex and delayed diagnostic journey when dealing with new cognitive concerns. High-performance testing with our PrecivityAD2 blood test has the potential to provide clarity and shorten that diagnostic journey, while significantly elevating healthcare quality.” The research builds on a large clinical study published in 2024 in the Journal of the American Medical Association (JAMA) that examined the ability of the PrecivityAD2 blood test’s APS2 result to improve the diagnostic accuracy of AD in primary care settings, where most patients with cognitive concerns turn to for initial answers about their memory loss. The study found similar robustness for the APS2 result in patients who saw memory care specialists. The APS2 delivered a highly statistically significant accuracy of over 90% at a pre-defined, single binary cutoff compared to cerebrospinal fluid (CSF) analysis or amyloid PET analysis. The QUIP II study reinforces the findings of the original QUIP I study, which evaluated the PrecivityAD® blood test with 43 memory care specialists caring for 366 patients; QUIP I was one of the first clinical utility studies that examined the real-world impact of a blood biomarker test for aiding in AD diagnosis and management. In that study, the PrecivityAD test provided clinically informative results in approximately 85% of cases and enabled clinicians to more confidently rule in or rule out a diagnosis of clinical AD. Both the PrecivityAD2 and PrecivityAD blood tests are accessible by order of a healthcare provider. They are available in 49 states in the U.S., excluding New York (where certification is pending), as well as the District of Columbia and Puerto Rico. About C2N Diagnostics, LLC C2N Diagnostics is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health. C2N’s high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. C2N assays have been used in over 150 Alzheimer’s disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies that are changing the trajectory of Alzheimer’s disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer’s Association, and other non-profits and consortiums. Over 30,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review. C2N has partnered with numerous leading clinical diagnostic labs throughout the world to offer expanded Precivity™ testing access to providers and patients, including Unilabs primarily across Europe, Grupo Fleury in Brazil and Healius Pathology in Australia for clinical use, and with Mediford Corporation in Japan for research purposes. C2N also recently announced it entered into a non-exclusive agreement with Mayo Clinic Laboratories. The company acknowledges generous support from National Institute on Aging, GHR Foundation, Alzheimer’s Drug Discovery Foundation, Alzheimer’s Association and BrightFocus Foundation. For more information visit www.C2N.com .

Clinical Result

100 Deals associated with Lecanemab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Lecanemab	-	DB14580

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Dementia due to Alzheimer's disease (disorder)	GB	Eisai Europe Ltd.	22 Aug 2024
Mild cognitive disorder	GB	Eisai Co., Ltd.	22 Aug 2024
Alzheimer Disease	US	Eisai, Inc.	06 Jan 2023

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cognitive Dysfunction	Phase 1	JP	Eisai Co., Ltd.	01 Sep 2013
Brain Injuries, Traumatic	Preclinical	US	BioArctic AB	15 Nov 2023
Down Syndrome	Preclinical	US	BioArctic AB	15 Nov 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03887455 (Clarity AD, PRNewswire) Manual	Phase 3	Alzheimer Disease	1,795	lecanemab	hkgkhlpmzt(rxgenvriya) = hmtlluozhv ayojdtmreq (uoxabdfabv ) View more	Positive	30 Jul 2024
				Placebo	hkgkhlpmzt(rxgenvriya) = ogloyiuxhg ayojdtmreq (uoxabdfabv )
NCT03887455 (Clarity AD, Pubmed) Manual	Phase 3	Alzheimer Disease ApoE e4 carriers \| ApoE ε4 homozygous participants	3,407	Lecanemab 10 mg/kg biweekly	bdmdmgcdlo(zcakkmrgei) = cndsvqglrw wbhgyejsac (sswbuhgbsa ) View more	Positive	10 May 2024
				placebo (Core Study)	bwhrkqhchg(guarcgpazy) = dehzrbyjiy lzcahhgqid (yhvommbmfm )
NCT03887455 (Clarity AD, AAN2024)	Phase 3	Alzheimer Disease amyloid PET centiloid levels	-	Lecanemab 10 mg/kg biweekly	ntjtamvydj(kkefobpney) = hebgttzmgq eqvjceprgh (oexoipucmq )	Positive	09 Apr 2024
				Placebo	ntjtamvydj(kkefobpney) = sdnudiptjc eqvjceprgh (oexoipucmq )
NCT03887455 (Clarity AD, PRNewswire \| NEWS \| Corporate Publications) Manual	Phase 3	Alzheimer Disease	898	LEQEMBI (SC)	gjpnylqcig(ibdmpmqiol) = inubsvarrt apslxvjlak (gvvuwknosj, 2.27) View more	Positive	25 Oct 2023
				LEQEMBI (IV)	gjpnylqcig(ibdmpmqiol) = daqygqnhyr apslxvjlak (gvvuwknosj, 1.14) View more
NCT03887455 (Clarity AD, FDA) Manual	Phase 3	Alzheimer Disease ApoE ε4	1,464	LEQEMBI 10 mg/kg	tqmnomvves(hxyayivqgl) = ccwlcsbzpw zgbvzbzjpj (iaqmitbpoa ) Met View more	Positive	06 Jan 2023
				Placebo	tqmnomvves(hxyayivqgl) = xpegdlwnxg zgbvzbzjpj (iaqmitbpoa ) Met View more
NCT01767311 (FDA) Manual	Phase 2	Alzheimer Disease ApoE ε4	315	LEQEMBI 10 mg/kg	hxbpmgcgio(xwrfltsasb) = egpaeefpdg fakqimsirw (sqkrzszyuq, -3.91 to -0.72) View more	Positive	06 Jan 2023
				placebo	ghugoqsnpf(cnmwqfnioe) = gxeaavstbg uemypkhbat (lapyrmcimr ) View more
NCT01767311 \| NCT02956486 \| NCT03887455 (AAIC2022)	Not Applicable	Alzheimer Disease PET \| CSF	-	Lecanemab	pegmkxkflj(pbgwetansq) = gemjmvgkxq qeneieutck (ieysmtuggq ) View more	-	20 Dec 2022
				Elenbecestat	pegmkxkflj(pbgwetansq) = mpxxgimekr qeneieutck (ieysmtuggq ) View more
Study 201 Core (AAIC2022)	Not Applicable	APOE4 genotype	856	Lecanemab 10 mg/kg Q2W	qcclyigoqs(stbeqtjbmq) = wgparkvxyv ygfnfwxxto (milsyfjstr )	-	20 Dec 2022
NCT01767311 (BAN2401-G000-201, AAIC2022)	Phase 2	Alzheimer Disease	-	Lecanemab	ktqcexknxx(pskcxfiool) = nnwyzmunce pupxzeeont (udfbyvymmy )	-	20 Dec 2022
Study 201 (AAIC2022)	Not Applicable	-	854	Lecanemab 10 mg/kg biweekly	lwvmnqwlhv(xnzlltyhrr) = cdvrtpgwqh wxoleoaike (rfhtxhnatu )	-	20 Dec 2022
				Placebo	lwvmnqwlhv(xnzlltyhrr) = uuajculxhk wxoleoaike (rfhtxhnatu )

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