Leqembi (lecanemab)

To treat Alzheimer’s disease Press Release Drug Trials Snapshot

FDA Approval: 1/6/2023

Research Synopsis

  • Lecanemab (Leqembi) is an FDA-approved monoclonal antibody targeting amyloid beta (Aβ) protofibrils specifically designed for treating early-stage Alzheimer's Disease (AD).
  • Recent studies highlight lecanemab's efficacy in reducing amyloid levels and clinical decline, particularly noted in an 18-month clinical trial where it showed positive outcomes compared to a placebo.
  • The mechanism of action emphasizes the importance of Aβ clearance, reflecting a broader focus on understanding neuroinflammatory processes in AD and how they relate to cognitive function.
  • Significant research is being conducted on proteins such as cathepsin B that modulate microglial activity, further illustrating the interplay between Aβ clearance and neuroinflammation.
  • New therapeutic approaches, including lecanemab, aim to address previous challenges in anti-Aβ immunotherapies that have often led to negative trial results or serious issues such as amyloid-related imaging abnormalities (ARIA).
  • Emerging evidence suggests that treatments like lecanemab might also benefit patients with genetic predispositions to Alzheimer’s, such as those with Down syndrome, by preserving cognitive function.
  • There is ongoing interest in the development of sophisticated methodologies for tracking neuroinflammatory biomarkers that could lead to enhanced individual treatment strategies.
  • Overall, advancements in amyloid-targeting therapies, including lecanemab, have generated optimism about their potential role in modifying the disease’s progression and improving patient outcomes.
  • The scientific community is cautiously hopeful about the future of monoclonal antibodies in AD treatment as further exploration and refinement of trial designs continue to yield crucial insights.

Related articles

Research articles about Leqembi (lecanemab)

Leqembi (lecanemab)

Emerging Roles of Adaptive Immune Response in Alzheimer's Disease.

London, UK

2 hours ago

1 Received

  • Alzheimer's disease (AD) is a brain illness that makes people forget things and leads to other thinking problems as it gets worse over time.
  • The disease has bad stuff called amyloid plaques and tangles that mess up the brain, and current medicines mainly help with symptoms instead of fixing the disease.
  • Some new treatments focus on removing the amyloid plaques but had side effects in humans; however, certain antibody therapies have been approved, and researchers are looking into better ways to treat AD.

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Tracking neuroinflammatory biomarkers in Alzheimer's disease: a strategy for individualized therapeutic approaches?

London, UK

2 hours ago

1 Received

  • Recent drugs for Alzheimer's disease have not worked well and can cause serious problems.
  • Scientists are looking at how inflammation in the brain might be linked to Alzheimer's and how it changes over time.
  • New blood tests could help doctors understand Alzheimer's better and match treatments to individual patients based on their specific symptoms.

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$100 - $150

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Can Targeted Protein Degradation Technology Provide a Potential Breakthrough in the Development of Anti-AD Drugs?

London, UK

2 hours ago

1 Received

  • Scientists have made new discoveries about Alzheimer’s disease (AD) and found two treatments called lecanemab and donanemab that work well!
  • Researchers are excited about tiny medicines that can break down amyloid-beta (Aβ), which could improve how we treat AD!
  • Even though there are some challenges, these new treatments might be the future solution for Alzheimer’s, thanks to recent scientific progress!

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Safety and tolerability of BAN2401--a clinical study in Alzheimer's disease with a protofibril selective Aβ antibody.

London, UK

2 hours ago

1 Received

  • BAN2401 is a monoclonal antibody developed for treating Alzheimer's disease by targeting soluble amyloid beta protofibrils.
  • A clinical study assessed its safety and tolerability in patients with mild to moderate Alzheimer's, using various dosing strategies while monitoring for amyloid-related imaging abnormalities (ARIA) via MRI.
  • Results showed that BAN2401 was well-tolerated and had a predictable pharmacokinetic profile, leading to the initiation of a Phase 2b efficacy study, although no significant effects on cerebrospinal fluid biomarkers were observed.

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The potential of solanezumab and gantenerumab to prevent Alzheimer's disease in people with inherited mutations that cause its early onset.

London, UK

2 hours ago

1 Received

  • Recent failures in anti-β-amyloid drug trials for Alzheimer's have led to a shift towards earlier interventions, initiating secondary prevention trials in individuals with genetic risks (autosomal-dominant AD) and those without cognitive dysfunction but at risk for sporadic AD.
  • The focus is on testing anti-β-amyloid monoclonal antibodies, specifically solanezumab and gantenerumab, in Phase III trials, while also being explored in the DIAN-TU network.
  • The goal of these trials is to determine if treatment during the preclinical stage can halt the progression of Alzheimer's disease before symptoms arise, validating the Aβ hypothesis as a viable target for prevention.

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Promising Results in 18-Month Analysis of Alzheimer Drug Candidate.

London, UK

2 hours ago

1 Received

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Passive antiamyloid immunotherapy for Alzheimer's disease.

London, UK

2 hours ago

1 Received

  • Antiamyloid therapy aims to reduce amyloid-beta peptide (Aβ) associated with Alzheimer's disease, focusing on immunotherapeutic trials with monoclonal antibodies.
  • Between 2016 and 2019, 43 studies were published on this topic, involving 17 randomized-controlled trials, but most results were negative, with many studies not meeting primary endpoints or being discontinued.
  • The high occurrence of amyloid-related imaging abnormalities (ARIAs) raises concerns about the safety of these treatments, suggesting that ongoing research should explore their benefits in asymptomatic individuals with genetic risk for early-onset Alzheimer's.

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Aducanumab, gantenerumab, BAN2401, and ALZ-801-the first wave of amyloid-targeting drugs for Alzheimer's disease with potential for near term approval.

London, UK

2 hours ago

1 Received

  • There's strong evidence that beta amyloid (Aβ) plays a key role in Alzheimer's disease, but only a few treatments have shown real success in trials.
  • Four promising agents – aducanumab, gantenerumab, BAN2401, and ALZ-801 – have unique characteristics and varying levels of effectiveness against Aβ.
  • The effectiveness of these treatments is influenced by their ability to target neurotoxic Aβ oligomers, with some focusing more on soluble forms while others help clear plaques, but higher doses can lead to side effects like brain edema, especially in certain patient groups.

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SPECT imaging of distribution and retention of a brain-penetrating bispecific amyloid-β antibody in a mouse model of Alzheimer's disease.

London, UK

2 hours ago

1 Received

  • The study investigates the long-term brain distribution of two monoclonal antibodies, RmAb158 and RmAb158-scFv8D3, aimed at targeting amyloid-β in Alzheimer's disease.
  • Using transgenic mice, researchers measured how these antibodies behaved in the brain over four weeks and found that the bispecific antibody RmAb158-scFv8D3 had faster brain uptake and better uniformity in distribution compared to RmAb158.
  • The findings suggest that receptor-mediated transport mechanisms enhance the effectiveness of antibody-based therapies by improving brain uptake and interaction with amyloid pathology, which may be beneficial for Alzheimer's treatment.

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Passive immunotherapies targeting Aβ and tau in Alzheimer's disease.

London, UK

2 hours ago

1 Received

  • Amyloid-β and tau proteins are key targets in Alzheimer's disease treatment, with passive immunotherapy using antibodies as a leading strategy.
  • The review highlights the complex challenges in developing effective therapeutic antibodies, focusing on the need for selective targeting of misfolded proteins and minimizing harm to healthy tissue.
  • Current clinical trials are exploring innovative solutions to these challenges, including strategies for antibody design and methods to clear pathological proteins without triggering damaging inflammation.

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A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody.

London, UK

2 hours ago

1 Received

  • - Lecanemab (BAN2401) is an antibody designed to target forms of amyloid beta linked to Alzheimer's, tested in a double-blind trial comparing it with a placebo in early-stage disease.
  • - The trial aimed to find an effective dose (ED90) that reduces clinical decline by at least 25% compared to placebo, using various assessment scales and brain imaging techniques over 12 and 18 months.
  • - Although the initial 12-month results did not meet the effectiveness threshold, by 18 months, lecanemab showed promising reductions in amyloid levels and clinical decline, while being well-tolerated by participants with a low incidence of adverse effects.

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Aducanumab produced a clinically meaningful benefit in association with amyloid lowering.

London, UK

2 hours ago

1 Received

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Critical Appraisal of Amyloid Lowering Agents in AD.

London, UK

2 hours ago

1 Received

  • The amyloid cascade hypothesis suggests that clearing amyloid beta (Aβ) could potentially cure Alzheimer's disease (AD), but previous treatments have shown limited success, prompting researchers to explore new therapeutic strategies like immunotherapy.
  • Currently, several monoclonal antibody (mAb) therapies aimed at targeting and removing Aβ plaques are under development, including aducanumab, lecanemab, solanezumab, crenezumab, donanemab, and gantenerumab, which could be effective at various stages of AD.
  • The FDA's upcoming decision on aducanumab is expected to significantly influence the future of mAb drug development for AD, and there's a call for improved trial designs to enhance treatment outcomes and

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Neurotoxic Soluble Amyloid Oligomers Drive Alzheimer's Pathogenesis and Represent a Clinically Validated Target for Slowing Disease Progression.

London, UK

2 hours ago

1 Received

  • Research indicates that soluble beta amyloid oligomers are key contributors to the development of Alzheimer's disease (AD).
  • Recent clinical trials suggest that targeting these oligomers, rather than just clearing amyloid plaques, is necessary for effective treatment of AD symptoms.
  • Successful agents in these trials, including several antibodies and an oral medication, show that reducing Aβ neurotoxicity can also decrease tau pathology, linking the two processes in the progression of AD.

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Elevated soluble amyloid beta protofibrils in Down syndrome and Alzheimer's disease.

London, UK

2 hours ago

1 Received

  • Down syndrome (DS) results from an extra copy of chromosome 21, leading to early onset of amyloid β (Aβ) brain pathology and subsequent cognitive decline.
  • Research involving brain samples shows that individuals with DS have higher levels of certain Aβ species compared to non-demented controls, indicating significant brain changes.
  • The drug lecanemab has shown promise in early trials for preserving cognitive function in DS, and it is now being tested in a phase 3 clinical trial.

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Significance of Oligomeric and Fibrillar Species in Amyloidosis: Insights into Pathophysiology and Treatment.

London, UK

2 hours ago

1 Received

  • Amyloidosis involves a range of diseases where proteins misfold and form harmful aggregates called amyloid fibrils, raising questions about their role in tissue damage.
  • Research suggests that smaller globular structures related to amyloid fibrils may contribute to nerve damage and degeneration.
  • New treatments targeting amyloid aggregates, like monoclonal antibodies (e.g., aducanumab), have been approved or are in development, emphasizing the need for better clinical assessment tools to track patient progress.

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Novel multivalent design of a monoclonal antibody improves binding strength to soluble aggregates of amyloid beta.

London, UK

2 hours ago

1 Received

  • Amyloid-β immunotherapy is gaining attention as a potential treatment for Alzheimer's disease, with several monoclonal antibodies in clinical trials; two are in phase 3, and one has already been FDA approved.
  • The focus of the research is on creating an enhanced hexavalent antibody based on mAb158, which targets toxic Aβ protofibrils, and evaluating its binding properties and protective capabilities against Aβ-induced cell damage.
  • Results show that the hexavalent antibody design significantly improves binding to protofibrils (40 times more effective) and effectively interacts with various Aβ aggregates, demonstrating potential as a therapeutic option for Alzheimer's disease.

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Aducanumab and the "post-amyloid" era of Alzheimer research?

London, UK

2 hours ago

1 Received

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Talking points for physicians, patients and caregivers considering Aduhelm® infusion and the accelerated pathway for its approval by the FDA.

London, UK

2 hours ago

1 Received

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