Kisunla (donanemab-azbt) / Eli Lilly - LARVOL DELTA

A Study on the Efficacy, Safety, and Health Economics of Donanemab Treatment for Alzheimer's Disease in the Real World (ChiCTR) - P4 | N=200 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Guangzhou Medical University; The Second Affiliated Hospital of Guangzhou Medical University

HEOR • New P4 trial • Real-world evidence • Alzheimer's Disease • CNS Disorders

AMYLOID-RELATED IMAGING ABNORMALITIES (ARIA) AFTER DONANEMAB-AZBT TREATMENT IN A PATIENT WITH RAPID COGNITIVE DETERIORATION (CHEST 2026) - No abstract available

Clinical • Critical care

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

SSKM administers first US-approved Alzheimer’s drug in east India (The Times of India) - "While the therapy is for 18 months, during which the 72-year-old needs to take the drug every month, doctors and the family hope the treatment will stall the progression of the disease...'To be administered once a month as an intravenous infusion, it is known to remove amyloid plaques, the toxic peptide from the brain. This drug is meant for patients with mild cognitive impairment due to Alzheimer’s disease.'....But doctors pointed out that Lormalzi (Donanemab), the new medicine approved by the US FDA for Alzheimer’s Disease was meant for patients in the early stage of the progression. Amyloid deposits in the brain are associated with Alzheimer’s disease."

Clinical • Alzheimer's Disease

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

A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease (clinicaltrials.gov) - P2/3 | N=240 | Recruiting | Sponsor: Banner Health | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • APOE

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

Rapid plaque clearance with anti-amyloid therapy for Alzheimer's disease: in consideration of donanemab treatment duration from real-world cases. (PubMed, Neurocase) - "Early cessation following rapid plaque clearance could reduce healthcare costs and minimize exposure to the risk of amyloid-related imaging abnormalities and the generation of neutralizing antibodies. Plasma P-tau217 warrants further investigation as a reliable, cost-effective surrogate for PET scans to monitor real-time treatment response and guide the timing of discontinuation."

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

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

Can Telehealth Improve Access to Amyloid-Targeting Therapies for Veterans Living With Alzheimer Disease? (PubMed, Fed Pract) - "Amyloid-targeting therapies, such as lecanemab and donanemab, offer new hope for managing Alzheimer disease (AD). The VHA is well-positioned to use a hybrid approach-both telehealth and in-person care-to support the provision of amyloid-targeting therapies for veterans with AD. Lessons learned can be extended to non-VHA care settings to achieve potential benefits for other patients with early AD."

Journal • Alzheimer's Disease • CNS Disorders • Dementia

Real-world evidence for amyloid-targeted therapies: Lecanemab and donanemab. (PubMed, Alzheimers Dement (Amst)) - "In a real-world cohort representing patients excluded from trials, ARIA and IRR rates matched or improved upon pivotal trials, supporting safe ATT use under FDA-approved MRI intervals."

HEOR • Journal • Real-world evidence • Alzheimer's Disease • CNS Disorders • Hematological Disorders • Immunology

Estimating treatment effects in clinical studies of Alzheimer's disease: What are estimands and why do we need them? (PubMed, Alzheimers Dement) - "In Alzheimer's disease (AD), potential ICEs include additional AD medication use, discontinuation of treatment, and death. We describe estimands in recent clinical studies of anti-amyloid therapies, including gantenerumab, lecanemab, and donanemab, in AD and use the evoke and evoke+ studies of semaglutide in early-stage symptomatic AD as examples of estimand application in AD trials."

Journal • Review • Alzheimer's Disease • CNS Disorders

Considerations for using amyloid-targeting therapies for the treatment of early symptomatic Alzheimer's disease. (PubMed, Front Neurol) - "Amyloid-targeting therapies (ATTs), including donanemab and lecanemab, are FDA-approved disease-modifying therapies for Alzheimer's disease in the mild cognitive impairment or mild dementia stages. Successful ATT implementation requires coordinated systems, timely diagnosis, and robust safety monitoring. These measures can enable frameworks for ATT administration to optimize outcomes for patients, care partners, and health systems."

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

Donanemab for early symptomatic AD in the UK-indicated population: safety and efficacy in those who are non-carriers or heterozygous for APOE ε4. (PubMed, Neurodegener Dis Manag) - P2, P3 | "Therefore, donanemab treatment requires structured risk-benefit discussion and appropriate monitoring. ClinicalTrials.gov, NCT03367403, https://clinicaltrials.gov/study/NCT03367403 (TRAILBLAZER-ALZ) and NCT04437511, https://clinicaltrials.gov/study/NCT04437511 (TRAILBLAZER-ALZ 2)."

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

Biomarkers, Diagnostics, and Emerging Therapies in Alzheimer's Disease: A Comprehensive Systematic Review (2015-2025). (PubMed, Cent Nerv Syst Agents Med Chem) - "This review highlights the critical need for future AD research to bridge identified gaps in early detection, focus on improving early diagnosis, developing more effective treatments, refining existing drugs and therapies, and understanding the underlying disease progression mechanisms."

Biomarker • IO biomarker • Journal • Alzheimer's Disease • CNS Disorders • Gene Therapies • Infectious Disease • Vascular Neurology

Real-world determinants of time to initiation of anti-amyloid treatments: comparative data from private and academic practice settings. (PubMed, Alzheimers Dement (Amst)) - "Patients with private insurance may experience greater delay in DTT, whereas BBBs may reduce DTT relative to traditional confirmatory biomarkers. DTT improves with clinic experience."

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

Beyond the Cochrane review: Re-evaluating anti-amyloid therapy in Alzheimer's disease. (PubMed, Alzheimers Dement) - "This statistical noise, compounded by a decade of failed studies, obscures the significant cognitive preservation achieved by U.S. Food and Drug Administration (FDA)-approved therapies, like lecanemab and donanemab. We emphasize current stratified safety frameworks for amyloid-related imaging abnormalities (ARIA) management. The path forward lies in an integrated framework combining Aβ clearance with novel, multi-pathway therapies."

Journal • Review • Alzheimer's Disease • CNS Disorders

Donanemab for early Alzheimer disease. (PubMed, Aust Prescr) - No abstract available

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

Post-marketing safety signals and report-level ARIA-E stratification for lecanemab and donanemab: an integrated FAERS and WHO-VigiAccess pharmacovigilance study. (PubMed, Ther Adv Drug Saf) - "ARIA-related and other neurological events remain the principal post-marketing safety concern for lecanemab and donanemab. The XGBoost model may support report-level risk prioritization, particularly during early treatment, but should not be used as a diagnostic substitute or a source of precise individualized risk estimates."

Adverse events • Journal • P4 data • Alzheimer's Disease • CNS Disorders

Experience with donanemab over a 1-year period: observations of side effects and compliance from a regional specialty medical center. (PubMed, Alzheimers Dement (Amst)) - "Donanemab may be safely used in a real-world setting with structured monitoring. ARIA was observed in 20.8% of patients in this implementation cohort. Larger-scale multicenter data are needed to benchmark rates."

Adverse events • Compliance • Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Hematological Disorders

The locus coeruleus gateway hypothesis: Noradrenergic integrity as a candidate determinant of amyloid-β clearance efficiency in anti-amyloid immunotherapy for Alzheimer's disease. (PubMed, J Alzheimers Dis) - "Anti-amyloid immunotherapies (lecanemab, donanemab) produce statistically significant but clinically modest slowing of decline in early Alzheimer's disease (AD), with substantial inter-individual response variability that current covariates-antibody titer, baseline amyloid load, apolipoprotein E ε4 (APOE4) status, or tau burden-leave largely unexplained. Its mediation chain is testable now in ADNI, which holds research-grade diffusion-tensor imaging; its treatment-response prediction requires immunotherapy cohorts that acquire such imaging, not the existing CLARITY-AD or TRAILBLAZER-ALZ 2 archives, whose safety MRI used diffusion-weighted, not tensor, sequences. We state explicitly that Aβ clearance is only one contributor to clinical benefit, and that the LCGH predicts pharmacodynamic efficiency, not that NE restoration treats AD."

Journal • Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder • APOE