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Donanemab – the third new Alzheimer’s Disease treatment under development

By Scientia Professor Henry Brodaty

Over the past two years, the development of three pharmaceutical treatments for Alzheimer’s dementia have achieve mixed results.

This article considers the latest treatment under development, donanemab, which recently achieved positive results in Phase 3 trials.

For information on the other two treatments, please read our earlier articles:

  • Aducanumab which was approved by the United States Food and Drug Administration (FDA) in June 2021 but is not available for use in Australia.
  • Lecanemab which was approved by the FDA in January 2023 but is also not available for use in Australia.

Similar to lecanemab, and aducanumab, donanemab aims to reduce amyloid in the brains of people with Alzheimer’s disease.

The makers of donanemab, Eli Lilly, found mixed results in their Phase 3 clinical trial. People with mild Alzheimer’s disease who received the new treatment showed 35% less decline over 18 months than those who received placebo. The treatment worked better in people whose brains contained only moderate levels of the tau protein that is associated with the progression of Alzheimer’s disease compared to those with high levels.

A major difference in the donanemab trial compared to the lecanemab trial, is that people stopped taking donanemab once their amyloid levels dropped below a certain threshold. About half of the trial participants were able to stop taking the drug in less than one year.

Similar to aducanumab, there were considerable side-effects reported for donanemab, including brain oedema (swelling) in 25% of participants, with 6% experiencing symptoms. There were two deaths. Microhaemorrhages occurred in 31% compared with 14% of participants taking placebo.

The full results are soon to be published and presented at a conference. Eli Lilly plan to apply for approval via the FDA in the US in the next few months.


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