Abstract

DONANEMAB: A NOVEL THERAPEUTIC APPROACH FOR ALZHEIMER’S DISEASE

Sayali Mane*, Mrs. Nita Khade, Harshada Gurav, Rutuja Mohite*, Sakshi Thorat, Resham Ingawle

ABSTRACT

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder characterized by memory loss, cognitive impairment, and functional decline, primarily associated with the accumulation of amyloid-β (Aβ) plaques and tau tangles in the brain. Donanemab, a humanized monoclonal antibody, represents a novel therapeutic strategy designed to selectively target N-terminal pyroglutamate amyloid-β, a highly pathogenic form of amyloid implicated in AD progression. Recent clinical trials have shown promising results, with donanemab demonstrating significant amyloid clearance and potential slowing of cognitive and functional decline compared to standard therapies. This review provides a comprehensive overview of donanemab, including its mechanism of action, pharmacological profile, clinical efficacy, safety outcomes, regulatory perspectives, and future opportunities. The implications of donanemab in reshaping AD management and challenges in its long-term use are also discussed.

Keywords: Donanemab, Alzheimer’s disease, amyloid-?, monoclonal antibody, neurodegeneration, clinical trials, immunotherapy.