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

Effective amyloid clearance with lecanemab in a female with Alzheimer's disease: A case report. (PubMed, Radiol Case Rep) - "This case illustrates substantial amyloid clearance with preserved cognitive and functional status after 18 months of lecanemab treatment without treatment-related safety concerns. Continued lecanemab therapy beyond 18 months may be feasible in carefully selected patients with early-stage AD, although further real-world data are needed to establish its long-term benefits and risks."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • CSF P-tau

Imaging for anti-amyloid therapy eligibility: Comparing GRE and SWI in detecting microhemorrhages and superficial siderosis. (PubMed, Alzheimers Dement (Amst)) - "SWI identifies more exclusionary hemorrhagic findings and demonstrates greater reproducibility than GRE."

Journal • CNS Disorders • Hematological Disorders

Cerebellar cortical amyloid deposition biases 18F-Florbetapir PET quantification with whole cerebellum as reference region. (PubMed, Eur J Nucl Med Mol Imaging) - "Cerebellar cortical Aβ deposition raises WC reference signals and interferes with CL-based 18F-Florbetapir Aβ PET quantification, which systematically underestimates true cerebral Aβ burden. The WM represents a robust reference region, and the cerebellar SUVRWM threshold of 0.428 is reliable and practical for identifying cerebellar cortical Aβ status."

Journal • Alzheimer's Disease • CNS Disorders

A Postmarketing Study of Lecanemab for the Treatment of Participants With Alzheimer's Disease (clinicaltrials.gov) - P=N/A | N=6700 | Recruiting | Sponsor: Eisai Inc.

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

Clinical Practice Outcomes With Lecanemab for Alzheimer Disease. (PubMed, Neurol Open Access) - "Although several markers showed modest negative predictive value, none reliably predicted ARIA. Improved markers to predict and monitor ARIA are needed to optimize cognitive outcomes."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Hematological Disorders • APOE • Aβ42

Anti-Amyloid Antibodies in the Treatment of Alzheimer's Disease: An Umbrella Review. (PubMed, J Clin Med) - "The purpose of this umbrella review is to summarize current knowledge concerning the efficacy and safety of FDA- and EMA-approved AAAs for AD, namely, lecanemab and donanemab. They are, however, associated with increased ARIA risk. Their administration depends upon careful patient selection, shared decision-making, and clear communication regarding expectations."

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

From Proof of Principle to Therapeutic Discipline: Strategies to Improve the Benefit/Risk Profile of Amyloid-Targeting Treatments for Alzheimer's Disease. (PubMed, CNS Drugs) - "Lecanemab and donanemab have both demonstrated statistically robust and clinically meaningful, albeit still modest, slowing of disease progression, thereby establishing disease modification as a realistic therapeutic objective rather than a speculative aspiration. Real-world registries will be essential to define long-term safety, effectiveness, and treatment patterns outside clinical trial populations. Therefore, future improvement of amyloid-targeting treatments is likely to come from widening the therapeutic margin by drug engineering as well as precision implementation in real-world settings."

Benefit-risk assessment • Journal • Alzheimer's Disease • CNS Disorders • APOE

Lower baseline cerebrospinal fluid amyloid-β 42 is associated with amyloid-related imaging abnormalities during real-world lecanemab treatment. (PubMed, J Alzheimers Dis) - "Aβ40 was also lower, whereas the Aβ42/Aβ40 ratio was not significantly different and tau biomarkers were not higher. Lower Aβ42 was associated with subsequent ARIA, but the internally derived cutoff requires external validation."

Journal • Real-world evidence • Alzheimer's Disease • CNS Disorders • Aβ42

Korea University Study Reveals How a Blood Biomarker Tracks Response to Lecanemab in Early Alzheimer's Disease (Yahoo Finance) - "Of the 153 patients, 81 had complete p-tau217 measurements at baseline, 3 months, and 6 months and were included in the analysis of distinct biomarker response patterns. Cognitive assessments were followed for 12 months...The researchers also found that baseline hypertension was independently associated with a weaker p-tau217 response. The greater-reduction group included 29 patients, compared with 52 in the lesser-reduction group. Hypertension was present in 10.3% of patients in the greater-reduction group and 42.3% of those in the lesser-reduction group...The greater-reduction group showed more favorable MMSE trajectories, while CDR-SB scores increased more slowly than in the lesser-reduction group. The difference in CDR-SB trajectories between groups was statistically significant (p < 0.001)."

Real-world • Alzheimer's Disease

Demographic and Clinical Characteristics of Patients Treated With Lecanemab Stratified by Amyloid-Related Imaging Abnormality Status. (PubMed, Cureus) - "Sex- and race/ethnicity-related differences were exploratory and require validation in larger, more diverse prospective cohorts. These findings support genotype-informed ARIA surveillance while emphasizing the need for broader representation in studies of anti-amyloid therapy safety."

Journal • Alzheimer's Disease • Cardiovascular • CNS Disorders • Diabetes • Dyslipidemia • Hypertension • Metabolic Disorders • APOE

Real-world anti-amyloid therapy beyond traditional symptomatic populations: a longitudinal case series. (PubMed, Front Psychiatry) - "We conducted a longitudinal retrospective case series of three biomarker-positive individuals from the Alzheimer's Disease Neuroimaging Initiative who received lecanemab or donanemab. Conventional global screening tools may underestimate early decline and affect treatment eligibility decisions. Although not generalizable, these observations underscore the need for larger real-world studies characterizing clinical trajectories following anti-amyloid therapy."

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

Antibody therapy in Alzheimer's disease (PubMed, Z Gerontol Geriatr) - "Lecanemab and donanemab, are the first disease-modifying antibodies available for early Alzheimer's disease. The risk is higher in APOE4 homozygotes, anticoagulation or cerebrovascular diseases. Therefore, during treatment a regular monitoring with magnetic resonance imaging (MRI) is mandatory."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Hematological Disorders • Vascular Neurology

Amyloid-β PET Radioligands in Alzheimer's Disease: From Plaque Detection to Biomarker-Guided Patient Stratification and Therapeutic Monitoring. (PubMed, Mol Diagn Ther) - "The regulatory approval of lecanemab and donanemab has recently expanded the clinical use of Aβ positron emission tomography. However, significant limitations remain, including the imperfect correlation between a high Aβ plaque burden and clinical cognitive decline that constrains its standalone diagnostic utility, tracer-specific variability, restricted accessibility, and the inability of fibril-targeted tracers to image the soluble oligomeric species most directly engaged by anti-Aβ antibodies. Probes for non-fibrillar species and computational tools for assisted interpretation are likely to shape the field in the near future."

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

Comparison table: Amyloid beta-directed antibodies for Alzheimer's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders • Dementia

Anti-amyloid treatment in Alzheimer disease: updated implications for patients with cerebral amyloid angiopathy and other cerebrovascular conditions. (PubMed, Front Neurol) - "Clinical trials of lecanemab and donanemab enrolled highly selected patients with minimal baseline cerebrovascular pathology, limiting generalizability to real-world populations with prevalent vascular comorbidity. Alternative strategies, including left atrial appendage closure, may be considered in selected patients, although evidence in AAT recipients remains limited. As AAT enters routine practice, multidisciplinary collaboration, dedicated imaging protocols, and prospective safety registries will be essential to integrate disease-modifying AD treatment with safe and effective cerebrovascular care."

Journal • Review • Alzheimer's Disease • Atrial Fibrillation • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Ischemic stroke • Vascular Neurology

Cross-disease protein aggregate interactions in neurodegeneration: from molecular mechanisms to therapeutic strategies. (PubMed, Neurol Sci) - "Recognition of cross-disease protein interactions necessitates a paradigm shift toward multi-target therapeutic strategies and precision medicine approaches accounting for individual co-pathology burden."

IO biomarker • Journal • Review • Alzheimer's Disease • CNS Disorders • TARDBP

More efficient screening for preclinical Alzheimer's clinical trials using mixture of experts. (PubMed, Alzheimers Dement) - "Blood plasma screening reduced participant and site burden, while preserving enrichment for amyloid positivity for a preclinical AD trial."

Biomarker • Journal • Preclinical • Review • Alzheimer's Disease • CNS Disorders

Baseline plasma C1q and C3 as potential biomarkers for lecanemab efficacy and ARIA risk in early Alzheimer's disease. (PubMed, Alzheimers Dement (N Y)) - "Lower baseline C3 was consistently associated with ARIA risk across sensitivity analyses and higher baseline C1q with smaller amyloid reduction at week 26. Findings are exploratory given the limited single-center sample."

Biomarker • Journal • Alzheimer's Disease • CNS Disorders • APOE

Arterial spin labeling-derived cerebral blood flow as a translational biomarker and candidate surrogate endpoint for cognitive impairment. (PubMed, Curr Opin Psychiatry) - "Within the FDA-NIH BEST framework, ASL-CBF appears to meet several criteria consistent with a reasonably likely surrogate endpoint, capturing upstream, potentially reversible hemodynamic dysfunction beyond established structural markers. CADASIL provides an optimal context for qualifications. Larger clinical trials linking treatment-induced CBF changes to clinical benefit, further protocol harmonization, and regulatory engagement are needed to translate ASL-CBF into a validated trial endpoint."

Biomarker • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Canada's Drug Agency Issues Final Positive Recommendation Supporting Public Reimbursement of LEQEMBI(R) (lecanemab) for Early Alzheimer's Disease (Streetinsider.com) - "The final recommendation follows a reconsideration by CDA-AMC and is an important step toward access to LEQEMBI. Next steps include negotiations through the pan-Canadian Pharmaceutical Alliance (pCPA), followed by individual reimbursement decisions by public drug plans in Canada's provinces and territories."

Reimbursement • Alzheimer's Disease

Ultrasound-Targeted Microbubble Cavitation-Assisted Brain Delivery of mAB-158 Reduces Amyloid Beta Burden (AHA 2026) - "Abstract is embargoed at this time."

Cardiovascular

Lecanemab in symptomatic PSEN1 p.Met233Val early-onset Alzheimer's disease: Neuroimaging safety, regional amyloid-PET dynamics, and longitudinal plasma biomarkers. (PubMed, Alzheimers Dement (Amst)) - "Lecanemab demonstrated neuroimaging safety and evidence of biological target engagement in this symptomatic PSEN1 p.Met233Val ADAD carrier. These longitudinal neuroimaging and plasma biomarker findings may help inform interpretation of treatment responses in genetically defined ADAD."

Journal • Alzheimer's Disease • CNS Disorders • Dementia • Dystonia • Movement Disorders • APOE • GFAP • NEFL • p-tau181

APOE ε4 genotype-dependent reduction of amyloid-related imaging abnormality in real-world lecanemab use: Implications for risk-stratified prescribing. (PubMed, J Alzheimers Dis) - "This pattern was observed for both ARIA subtypes across both settings. These early real-world findings suggest that the apparent attenuation of ARIA during the initial clinical introduction of lecanemab is consistent with genotype-informed risk selection rather than a uniform population-wide decrease."

Journal • Alzheimer's Disease • CNS Disorders • APOE

From public preferences to clinical tasks in anti-amyloid therapy for Alzheimer's disease. (PubMed, Psychiatry Clin Neurosci) - "Tajika and colleagues found that, among Japanese respondents willing to consider lecanemab, the median smallest worthwhile difference exceeded the absolute benefit used in their study scenario. This commentary argues that this expectation-efficacy gap should be translated into concrete clinical tasks across the anti-amyloid care pathway, including expectation assessment, biomarker and eligibility counseling, shared decision-making, treatment monitoring, support for non-initiation or discontinuation, and continuing psychosocial care."

Journal • Alzheimer's Disease • CNS Disorders

Final CDA-AMC Recommendation Brings Canadians with Early-Stage Alzheimer's Disease One Step Closer to Accessing LEQEMBI (lecanemab) (PRNewswire) - "The completion of CDA-AMC's review is a positive recognition of the value of LEQEMBI and paves the way for reimbursement discussions."

Reimbursement • Alzheimer's Disease