MedicalResearch.com Interview with:
Roger M. Nitsch, MD
Professor and Director
Institute for Regenerative Medicine · IREM
University of Zurich Campus Schlieren
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The main finding is that treatment with aducanumab resulted in an unprecedented reduction of brain amyloid plaques in patients with Alzheimer’s disease. The removal of amyloid from patients brains were both dose- and time-dependent. We also observed initial hints for stabilized brain functions in patients receiving aducanumab. In contrast, patients in the placebo group continued to declined as usual in this stage of Alzheimer’s disease.
The main safety finding in 22% of all treated patients was ARIA – an Amyloid-Related Imaging Abnormality – suggestive of fluid shifts in the brains. In most cases, ARIA occurred in the absence of clinical signs and resolved spontaneously. In one third of the ARIA cases, patients experienced transient headaches. None of the patients had to hospitalized because of ARIA.
MedicalResearch.com: What should readers take away from your report?
Response: If the outcomes of the current ongoing phase 3 clinical trials confirm the initial results published in Nature, we will have an effective treatment for Alzheimer’s disease.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Equally important prerequisites for successful drug development are effective and safe drug candidates, suitable clinical trial populations and intelligent trial design.
MedicalResearch.com: Is there anything else you would like to add?
Response: We thank all participating patients, their families and caregivers, as well as the hard-working staff supporting the principal investigators for their invaluable and outstanding contributions to the aducanumab trials.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Jeff Sevigny, Ping Chiao, Thierry Bussière, Paul H. Weinreb, Leslie Williams, Marcel Maier, Robert Dunstan, Stephen Salloway, Tianle Chen, Yan Ling, John O’Gorman, Fang Qian, Mahin Arastu, Mingwei Li, Sowmya Chollate, Melanie S. Brennan, Omar Quintero-Monzon, Robert H. Scannevin, H. Moore Arnold, Thomas Engber, Kenneth Rhodes, James Ferrero, Yaming Hang, Alvydas Mikulskis, Jan Grimm, Christoph Hock, Roger M. Nitsch, Alfred Sandrock.The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease. Nature, 2016; 537 (7618): 50 DOI:1038/nature19323
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