Leqembi (lecanemab-irmb) / Biogen, BioArctic, Eisai - LARVOL DELTA

The Clinical Trials Landscape for Alzheimer's Disease. (PubMed, CNS Neurosci Ther) - "Although most drugs treated AD abortively, the success of lecanemab and decanemab provides confidence for us to further study the pathogenesis of AD and explore new therapeutic targets to develop anti-AD drugs. Rising non-drug and non-therapeutic research will provide more possible methods for the treatment and prevention of AD in thefuture."

Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia

Self-reported quality of life in progressive cognitive decline-let's not throw the baby out with the bathwater. (PubMed, Qual Life Res) - "This commentary discusses current practices, highlighted by recent appraisals of lecanemab by NICE, where concerns about proxy-reported data-specifically, the risk of underestimating benefits-were noted as a limitation in the evaluation. While progressive cognitive decline complicates traditional self-reporting methodologies, emerging evidence demonstrates that adaptive strategies and technology-assisted methods can extend reliable self-reporting windows...Crucially, it calls for HEOR to integrate adaptive methods from adjacent fields-such as phenomenological inquiry, sensor technology, and data triangulation. These approaches can enhance the ability of HEOR to measure, value, and assess quality of life in the context of dementia and other progressive neurodegenerative conditions, ultimately anchoring value in lived experience and ensuring methodological limitations do not become barriers to accessing care and treatments."

HEOR • Journal • Alzheimer's Disease • CNS Disorders • Dementia

12-Month Real-World Safety & Efficacy of Lecanemab in Early Alzheimer's Disease (clinicaltrials.gov) - P4 | N=80 | Active, not recruiting | Sponsor: Ruijin Hospital

New P4 trial • Alzheimer's Disease • CNS Disorders

Imaging of Healthy Subjects using [11C]COU: Dosimetry, Metabolite Analysis, and Kinetics (SNMMI 2025) - "Recently, 2 anti-amyloid drugs have been approved by FDA for treatment of ADRD, lecanemab and donanemab. No adverse events were reported from any healthy subjects that participated in this study. The trapping rate of this tracer is extremely fast. This caused the estimates of the individual rate parameters k2 and k3 to be highly correlated and highly variable."

Clinical

Imaging of Healthy Subjects using [11C]COU: Dosimetry, Metabolite Analysis, and Kinetics (SNMMI 2025) - "Recently, 2 anti-amyloid drugs have been approved by FDA for treatment of ADRD, lecanemab and donanemab. No adverse events were reported from any healthy subjects that participated in this study. The trapping rate of this tracer is extremely fast. This caused the estimates of the individual rate parameters k2 and k3 to be highly correlated and highly variable."

Clinical

Amyloid Deposition and Amyloid Related Imaging Abnormalities: Centiloid and SUV Correlates (SNMMI 2025) - "Purpose/Background: Amyloid PET Centiloid score and regional SUV measurements are proposed to have a relationship with severity and regional involvement in amyloid related imaging abnormalities (ARIA) during lecanemab therapy... SUVpeak of brain regions later involved by ARIA was increased relative to the contralateral uninvolved brain (mean ARIA site SUV 2.32 vs contralateral 2.15, unpaired p 0.29 & paired p 0.009; 9 patients). ARIA severity grade also correlated with mean pretherapy Centiloid score (mild 52 [3 patients], moderate 77 [7 patients], and severe 102 [2 patients]; p 0.22), although a mild inverse association was demonstrated between ARIA incidence and pretherapy Centiloid score (p 0.19)/CSF amyloid beta level (p 0.16). Apolipoprotein ε4 homozygosity (OR 7.0, p .04), history of diabetes (OR 1.5, p 0.4) and >5 pack-year tobacco use (OR 1.9, p 0.22) correlated with ARIA incidence, and apolipoprotein ε2-3 homozygosity (OR 1.9, p 0.1) correlated with ARIA..."

Diabetes • Metabolic Disorders

Posterior cortical atrophy in the age of anti-amyloid treatments: An 11-year retrospective study of eligible patients from the Leenaards Memory Center. (PubMed, J Alzheimers Dis) - "In a retrospective analysis of the Leenaards Memory Center registry, we identified 41 PCA cases and, applying the recent appropriate use recommendations for lecanemab, estimate high (20%) eligibility rate, that doubles in pure PCA phenotypes with biomarker work-up available (40%). This high proportion of PCA patients eligible for AAT should prompt a timely exploration to assess inclusion/exclusion criteria for these novel therapies."

Journal • Retrospective data • Alzheimer's Disease • CNS Disorders

Genetically informed treatment in psychiatry: new dynamics through APOE and antibody treatment of Alzheimer's disease (PubMed, Nervenarzt) - "This is to reduce the risk of undesired adverse effects in the patients treated with Lecanemab. With this recommendation for the first time a psychiatric therapy will be genetically informed."

Journal • Review • Alzheimer's Disease • CNS Disorders • Psychiatry • APOE

NICE reaffirms negative stance on Alzheimer's therapies Kisunla, Leqembi (Firstwordpharma Press Release) - "The UK's National Institute for Health and Care Excellence (NICE) has again ruled that the benefits offered by two recently approved amyloid plaque-targeting therapies for Alzheimer's disease are too small to justify their additional cost to the NHS. The latest draft guidance, issued Thursday, reaffirms earlier decisions on Eli Lilly's Kisunla (donanemab) and Eisai's Leqembi (lecanemab), and comes ahead of a final ruling next month....As such, the final draft guidance concludes that neither drug can be recommended on the NHS for treating mild cognitive impairment or mild dementia caused by Alzheimer's disease."

NICE • Alzheimer's Disease

A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - P2 | N=105 | Active, not recruiting | Sponsor: Eisai Inc. | Recruiting ➔ Active, not recruiting

Biomarker • Enrollment closed • Alzheimer's Disease • CNS Disorders

Lecanemab (Leqembi) for the Slowing of Alzheimer Disease. (PubMed, Am Fam Physician) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders

Current advances and unmet needs in Alzheimer's disease trials for individuals with Down syndrome: Navigating new therapeutic frontiers. (PubMed, Alzheimers Dement) - "Recent breakthroughs in sporadic AD, including anti-amyloid therapies such as lecanemab and donanemab, have shown efficacy in slowing progression. Collaboration between advocacy groups, researchers, and pharmaceutical companies is essential for overcoming barriers in AD clinical trials for DS, including ethical concerns, recruitment challenges, and the need for adapted cognitive assessments. This perspective also proposes strategies to enhance inclusivity in future studies, ensuring broader access to emerging treatments."

Journal • Review • Alzheimer's Disease • CNS Disorders • Dementia • Developmental Disorders • Genetic Disorders • Inflammation • APP

A Quantitative Systems Pharmacology Model That Describes Neurofilament Light Dynamics During Alzheimer's Disease Progression. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "The model was validated against clinical data and demonstrated correct predictions for anti-tau therapy while showing a tendency to overestimate efficacy of anti-amyloid therapy (lecanemab). This supports the idea that amyloid therapy contribution to neurodegeneration is limited, and that treatment should focus on other mechanisms."

Journal • Alzheimer's Disease • CNS Disorders • Targeted Protein Degradation

Comparison of safety of lecanemab and aducanumab: a real-world disproportionality analysis using the FDA adverse event reporting system. (PubMed, Front Pharmacol) - "This study identified some new PT signals and some PT signals showed gender differences. The median time-to-onset of ADEs due to lecanemab is shorter than that due to aducanumab."

Adverse events • Journal • Real-world evidence • Alzheimer's Disease • CNS Disorders

Performance of a Statistically Based Centiloid Threshold and Expert Read of Vizamyl PET Against Histopathology [WITHDRAWN] (SNMMI 2025) - "Purpose/Background: Recently FDA-approved disease-modifying therapies such as Donanemab (Kisunla™; Eli Lilly) and Lecanamab (Leqembi®; Eisai & Biogen) have been shown to slow cognitive decline in Alzheimer’s Disease (AD) patients and are now being administered at multiple U.S. institutions.1,2 Both therapies require confirmation of beta-amyloid (Aß) pathology prior to treatment.3,4 A quantitative metric of Aß burden called Centiloid (CL), used in clinical trials for both therapies, is useful as an adjunct to visual read and offers a standardized measure of amyloid burden.1,2,5 Several commercially available software packages offer cleared-for-clinical-use quantitative tools, such as CL or statistical comparison to a normal database, that may provide clinical decision support for administering these therapies and tracking longitudinal changes. Classification accuracy metrics are shown in Table 1. Given a cutoff of 24.4 CL, the overall classification..."

Alzheimer's Disease • CNS Disorders

NHS patients with Alzheimer's WON'T access 'miracle' drugs as watchdog says they are 'too expensive' (MSN News) - "Two of the first drugs proven to slow down Alzheimer's disease will be denied to NHS patients from this week - unless they pay to go private. The National Institute for Health and Care Excellence (NICE) has refused the 'miracle' drugs lecanemab and donanemab for use on the NHS as they are too expensive to justify. This means over 70,000 patients in England will be denied the 'game-changing' drugs, found to slow cognitive decline by an average of four to seven months, unless they can afford tens of thousands of pounds a year for private treatment."

NICE • Alzheimer's Disease

Antiamyloid treatment for dementia: concerns outweigh hopes. (PubMed, Curr Opin Psychiatry) - "It is still uncertain about the place of MABs in the treatment of Alzheimer's dementia. Further research is required regarding the long-term benefits and risks."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • TARDBP

"Real-world" eligibility for anti-amyloid treatment in a tertiary memory clinic setting. (PubMed, Alzheimers Dement) - "Initial eligibility for lecanemab was 8% of all patients and 21% of those with clinical mild cognitive impairment (MCI) or Alzheimer's disease (AD) based on approved guidelines in a tertiary memory clinic population. After strict exclusions (such as apolipoprotein E ε4/ε4 homozygosity and anticoagulant use), eligibility dropped to 6% of all patients and 15% of those with clinical MCI or AD. The study highlights the limited real-world applicability of anti-amyloid treatment under current guidelines."

Journal • Real-world evidence • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • APOE

Alzheimer’s drugs expected to become available soon (Taipei Times) - "Two new drugs targeting early-stage Alzheimer’s disease are expected to be put into clinical use as soon as Thursday next week, following an approval from the Ministry of Health and Welfare last year. The new drugs, Leqembi, developed by US and Japanese researchers, and Kisunla, developed by Eli Lilly, target amyloid plaque in people’s brains, which can delay the disease’s progression...Although clinical data show that about 3 percent of people experienced hemorrhaging and 0.7 percent saw slowed neurological reactions, the drugs need further evaluation for long-term effects...Another concern is the cost, as much as NT$1 million (US$33,422) a year for treatment, excluding the expense incurred by other examinations..."

Launch non-US • Alzheimer's Disease

Implementation of Lecanemab for Alzheimer's Disease Within the Veterans Health Administration: Facilitators and Barriers. (PubMed, J Am Geriatr Soc) - "Attention to identified facilitators and barriers may be helpful for facilities implementing amyloid targeting therapy for AD."

Journal • Alzheimer's Disease • CNS Disorders

Lecanemab Binds to Transgenic Mouse Model-Derived Amyloid-β Fibril Structures Resembling Alzheimer's Disease Type I, Type II and Arctic Folds. (PubMed, Neuropathol Appl Neurobiol) - "Lecanemab binds to Aβ fibrils from several Alzheimer's disease tg-mice whose structures resemble the type I, type II and Arctic folds found in Alzheimer's patients, all of which share a flexible, unstructured N-terminus. Lecanemab is therefore expected to be active against all common familial and sporadic Alzheimer's cases containing these folds. Lecanemab binding ability is unaffected by and tolerates the Arctic E22G mutation, at least in type I or Arctic folds. Only weak, if any, lecanemab binding was observed to Aβ fibrils derived from tg-SwDI mice, whose structures DI1, DI2 and DI3 all share structured and fixed N-termini. Since the fixed N-termini of tg-SwDI DI1 fibrils and human meningeal Aβ40 fibrils derived from CAA-affected brain are identical, most likely preventing lecanemab binding, treatment with lecanemab may be less effective or ineffective against CAA, but may explain the reported beneficial low ARIA-E frequency with this antibody."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders

FDA-Approved Lecanemab Shows Reduced Side Effects in Real-World Use (GeneOnline) - "A recent evaluation of lecanemab, an Alzheimer’s treatment approved by the Food and Drug Administration in 2023, indicates that the drug has been well tolerated outside of clinical trial settings...However, concerns arose during clinical trials regarding potential side effects, including brain swelling and bleeding, which led to hesitation among some patients and healthcare providers. The findings suggest that these adverse effects may be less prevalent or manageable in real-world applications compared to controlled trial environments. The approval of lecanemab was initially met with optimism within the medical community due to its groundbreaking approach to addressing Alzheimer’s disease progression. Despite this enthusiasm, safety concerns highlighted during trials prompted caution among stakeholders. The latest observations provide additional insights into how the therapy performs beyond clinical settings..."

Real-world • Alzheimer's Disease

Cost-effectiveness of Lecanemab for the treatment of early Alzheimer's Disease: a Canadian societal perspective (CNSF 2025) - No abstract available

Cost effectiveness • HEOR • Alzheimer's Disease • CNS Disorders

Real-world evidence of Lecanemab use in the United States (CNSF 2025) - No abstract available

Clinical • HEOR • Real-world • Real-world evidence • CNS Disorders

A Real World Study of Lecanemab for Early Onset Familial Alzheimer's Disease (ChiCTR) - P=N/A | N=114 | Recruiting | Sponsor: Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine; Renji Hospital affiliated to Shanghai Jiaotong University School of Medi

New trial • Real-world evidence • Alzheimer's Disease • CNS Disorders