STM Journals Peer-reviewed research from Consortium e-Learning Network

Research and Reviews: A Journal of Neuroscience Original Research

Kisunla (Donanemab): A Novel Breakthrough Illuminating a Path to Better Alzheimer’s Outcomes

  1. Muchukota Sushma Department of Pharmacy Practice, Aditya Bangalore Institute of Pharmacy Education & Research (ABIPER), Yelahanka, Bangalore
  2. Alena Reji Thomas Department of Pharmacy Practice, Aditya Bangalore Institute of Pharmacy Education & Research (ABIPER), Yelahanka, Bangalore
  3. Jayashree S Department of Pharmacy Practice, Aditya Bangalore Institute of Pharmacy Education & Research (ABIPER), Yelahanka, Bangalore
  4. Priya Singha Department of Pharmacy Practice, Aditya Bangalore Institute of Pharmacy Education & Research (ABIPER), Yelahanka, Bangalore
  5. Payal Baral Department of Pharmacy Practice, Aditya Bangalore Institute of Pharmacy Education & Research (ABIPER), Yelahanka, Bangalore
  6. Isbha Stephen Department of Pharmacy Practice, Aditya Bangalore Institute of Pharmacy Education & Research (ABIPER), Yelahanka, Bangalore
  7. Shobha R. R. Hiremath Department of Pharmacy Practice, Aditya Bangalore Institute of Pharmacy Education & Research (ABIPER), Yelahanka, Bangalore

Abstract

Background: Alzheimer’s disease (AD) is a progressive neurodegenerative condition marked by cognitive decline, memory loss, and loss of independence. Despite decades of extensive research, disease-modifying treatments have been limited in success. Recent therapeutic advancements have led to the development of monoclonal antibodies targeting amyloid-beta (Aβ) plaques, particularly the pyroglutamate-modified variant, a key pathological hallmark of AD.

Objectives: This review aims to explore the therapeutic potential of Donanemab (Kisunla), a novel monoclonal antibody, in slowing disease progression in early symptomatic AD. The study also seeks to assess its clinical efficacy, safety profile, and regulatory journey, while comparing it to other amyloid-targeting therapies.

Methodology: A comprehensive analysis of published literature and clinical trial data was conducted, with a focus on the TRAILBLAZER-ALZ clinical programs. Key inclusion and exclusion criteria of the studies were assessed, and trial outcomes related to cognitive performance, amyloid clearance, and safety (especially amyloid-related imaging abnormalities-ARIA) were reviewed. Comparisons were drawn with other similar agents to evaluate relative effectiveness.

Results: Donanemab demonstrated significant efficacy in reducing amyloid burden and slowing cognitive decline in early symptomatic patients. The TRAILBLAZER-ALZ trials presented strong clinical evidence for amyloid clearance and improved patient outcomes. However, safety concerns, like ARIA, were reported and carefully monitored. Regulatory agencies acknowledged the potential of Donanemab, granting accelerated approvals based on trial outcomes.

Conclusion: Donanemab represents a promising advancement in AD therapeutics, potentially altering the treatment landscape through disease modification. Its early intervention approach and favorable efficacy outcomes indicate a hopeful shift in Alzheimer’s management, though long-term safety and comparative effectiveness require further evaluation.

Keywords

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