Promising New Antibody Therapy Shows Potential to Slow Alzheimer’s Progression
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Paris, France - 2025/09/21 – A novel antibody therapy, donanemab, has demonstrated a significant slowing of cognitive decline in individuals with early-stage Alzheimer’s disease, according to recently published results from a large-scale clinical trial. The findings, presented at the Alzheimer’s Association International Conference on 2025/07/22 and simultaneously published in JAMA, offer a renewed sense of hope in the fight against the devastating neurodegenerative disease.
Alzheimer’s disease affects over 6.7 million Americans, a number projected to reach 13.1 million by 2050, according to the Alzheimer’s Association. The economic burden is immense, costing the U.S. alone an estimated $345 billion in 2023. While existing treatments offer limited symptomatic relief, donanemab represents a potential disease-modifying approach, targeting the underlying pathology of Alzheimer’s – the accumulation of amyloid plaques in the brain. The trial results signal a critical turning point, suggesting that slowing, and possibly even preventing, the progression of Alzheimer’s may be within reach.
Targeting Amyloid Plaques
Donanemab, developed by Eli Lilly and Company, is a monoclonal antibody designed to clear amyloid plaques. The Phase 3 TRAILBLAZER-ALZ 2 trial involved 1,736 participants with early symptomatic Alzheimer’s disease and confirmed amyloid and tau pathology. Participants were randomly assigned to receive either donanemab administered intravenously every two weeks or a placebo.
The study revealed that donanemab slowed cognitive and functional decline by 22.3% compared to placebo after 76 weeks of treatment. Furthermore, 52.7% of participants receiving donanemab showed no clinical progression at one year, compared to 29.7% in the placebo group. Brain scans confirmed a ample reduction in amyloid plaques in the donanemab group.
“these results are encouraging and represent an significant step forward in our efforts to combat Alzheimer’s disease,” stated Dr. John Dwyer, a neurologist involved in the trial.”While not a cure,donanemab has the potential to considerably improve the quality of life for individuals in the early stages of the disease.”
Safety Considerations and Future Outlook
The therapy is not without risks. A significant side effect observed in the trial was ARIA (amyloid-related imaging abnormalities),brain swelling or microbleeds detected on MRI scans. ARIA occurred in 31.8% of donanemab recipients, with most cases being mild or asymptomatic. Though, serious ARIA events, including those requiring hospitalization, were reported in 3.6% of the donanemab group.
Eli Lilly has submitted donanemab for full approval to the U.S. Food and Drug Administration (FDA), with a decision expected in early 2026. The FDA previously granted accelerated approval to another amyloid-targeting therapy, lecanemab (Leqembi), in 2023.
Beyond donanemab, research into Alzheimer’s prevention and treatment is expanding rapidly. Ongoing studies are investigating other antibody therapies, as well as approaches targeting tau protein, neuroinflammation, and vascular health. Lifestyle interventions, including regular exercise, a healthy diet, and cognitive stimulation, are also being explored as potential preventative measures. Experts emphasize that a multi-faceted approach,combining pharmacological interventions with lifestyle modifications,will likely be crucial in tackling this complex disease.
