16 Mar Alzheimer’s Disease: Monoclonal Antibody Donanemab Reduced Amyloid, Slowed Cognitive Decline
MedicalResearch.com Interview with:
Stephen Salloway, M.D., M.S.
Director of Neurology and the Memory and Aging Program, Butler Hospital
Martin M. Zucker Professor of Psychiatry and Human Behavior
Professor of Neurology, Alpert Medical School of Brown University
Providence, RI 02906
MedicalResearch.com: What is the background for this study?
Response: This 78 week phase 2 study tested donanemab in patients with early Alzheimer’s disease. Donanemab is a an anti-amyloid monoclonal antibody that targets the N3 pyroglutamate epitope.
MedicalResearch.com: What are the main findings?
Response: The drug produced a substantial lowering of amyloid plaques and showed a slowing in cognitive decline. Key innovations included using PET scans to ensure all patients were amyloid positive and had a moderate level of tau build-up and switching from drug to placebo once the amyloid level was below the expected cut-off for Alzheimer’s disease.
There were no new safety signals. The main side-effect was amyloid-related imaging abnormalities (ARIA) that have been seen with other anti-amyloid treatments. ARIA is managed with regular safety MRI scans. Donanemab is now being tested in a larger phase 3 trial that could lead to regulatory approval.
MedicalResearch.com: What should readers take away from your report?
Response: These encouraging results mean that we are getting close to a breakthrough for Alzheimer’s disease. We are also testing drugs like donanemab to prevent memory loss in people at risk for Alzheimer’s disease.
Disclosures: was a site investigator for the donanemab study and I provide consultation to Lilly. I own no stock options and have no equity interest in donanemab.
Mintun MA, Lo AC, Duggan Evans C, Wessels AM, Ardayfio PA, Andersen SW, Shcherbinin S, Sparks J, Sims JR, Brys M, Apostolova LG, Salloway SP, Skovronsky DM. Donanemab in Early Alzheimer’s Disease. N Engl J Med. 2021 Mar 13. doi: 10.1056/NEJMoa2100708. Epub ahead of print. PMID: 33720637
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