--- title: FDA Grants Breakthrough Therapy Designation to Donanemab, Investigational Alzheimer's Drug description: The FDA Breakthrough Therapy designation is based on clinical evidence for donanemab demonstrated in the drug's Phase 2 trial, TRAILBLAZER-ALZ, conducted in part at the Memory and Aging Program at Butler Hospital. image: https://www.butler.org/hubfs/-%20BUTLER/download.jpg --- - [**Pay My Bill](https://www.carenewengland.org/pay/butler-hospital/) - [**Careers](https://www.butler.org/careers) - [**Donate](https://www.butler.org/ways-to-give) - [**My Chart](https://www.carenewengland.org/mychart) - [**+1 (844) 401-0111](tel:+1%20(844)%20401-0111) [![CNE Butler Behavioral Health](https://www.butler.org/hs-fs/hubfs/-%20CNE/CNE%20-%202026%20Branding/CNE%20Butler%20Behavioral%20Health.png?width=1200&height=475&name=CNE%20Butler%20Behavioral%20Health.png)](https://www.butler.org/) ** #### Site Search ** ** ![ # FDA Grants Breakthrough Therapy Designation to Donanemab, Investigational Alzheimer's Drug [![Memory and Aging Home](https://no-cache.hubspot.com/cta/default/6898349/eeeb8931-f74d-4d06-b8e6-7f218fca51ea.png)](https://cta-redirect.hubspot.com/cta/redirect/6898349/eeeb8931-f74d-4d06-b8e6-7f218fca51ea)   [![Clinical Trials](https://no-cache.hubspot.com/cta/default/6898349/195ac971-e993-4ccb-93e6-a9107c1092e6.png)](https://cta-redirect.hubspot.com/cta/redirect/6898349/195ac971-e993-4ccb-93e6-a9107c1092e6)  [![Prevention Registry](https://no-cache.hubspot.com/cta/default/6898349/f15528e5-3c25-4ab1-b725-ac8468609172.png)](https://cta-redirect.hubspot.com/cta/redirect/6898349/f15528e5-3c25-4ab1-b725-ac8468609172)  [![News & Events](https://no-cache.hubspot.com/cta/default/6898349/faf3de21-22f4-42e9-b15c-5ed7ef5b4bb7.png)](https://cta-redirect.hubspot.com/cta/redirect/6898349/faf3de21-22f4-42e9-b15c-5ed7ef5b4bb7)  [![Volunteer](https://no-cache.hubspot.com/cta/default/6898349/94f16df1-1430-4aad-b1bf-b4c32d45ebc6.png)](https://cta-redirect.hubspot.com/cta/redirect/6898349/94f16df1-1430-4aad-b1bf-b4c32d45ebc6)   News from the [Memory and Aging Program at Butler Hospital](https://www.butler.org/memory) June 24, 2021   The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to donanemab, an investigational antibody therapy for Alzheimer's disease (AD). The Breakthrough Therapy designation aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over already available therapies that have received full FDA approval.   The designation is based on clinical evidence for donanemab demonstrated in the drug's Phase 2 trial, TRAILBLAZER-ALZ, conducted in part at the Memory and Aging Program at Butler Hospital. Read more about the designation in this [press release](https://www.prnewswire.com/news-releases/lillys-donanemab-receives-us-fdas-breakthrough-therapy-designation-for-treatment-of-alzheimers-disease-301318931.html) from the drug's maker, Eli Lilly.   The results of the TRAILBLAZER-ALZ study were reported in the New England Journal of Medicine in March. Stephen Salloway, MD, MS, director of the Memory and Aging Program and of Neurology at Butler Hospital and the Martin M. Zucker professor of Psychiatry and Human Behavior and professor of Neurology at the Warren Alpert Medical School of Brown University, is a co-author of the NEJM article. He was principal investigator for the [TRAILBLAZER](https://www.butler.org/studies/trailblazer-alz) study at Butler Hospital and was a lead investigator on the trial.   [Read more about the trial results >](https://www.butler.org/memoryandaging/second-drug-studied-at-butler-shows-significant-results-slowing-alzheimers) [Learn more about the TRAILBLAZER-ALZ Study >](https://www.butler.org/studies/trailblazer-alz)     ### Explore More from The Memory and Aging Program at Butler Hospital   - [Memory and Aging Program Home](https://www.butler.org/memory) - [Clinical Trials for Alzheimer's Prevention and Treatment](https://www.butler.org/memory/clinical-trials) - [Join the Alzheimer's Prevention Registry](https://www.butler.org/memory/alzheimers-prevention-registry) - [News and Events](https://www.butler.org/memoryandaging) - [Volunteer](https://www.butler.org/memory/volunteer) - [Donate](https://www.butler.org/memory/donate) ***Disclaimer: ****The content in this blog is for informational and educational purposes only and should not serve as medical advice, consultation, or diagnosis. 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