Alzheimer’s Disease: Solanezumab Trials for Mild to Moderate Disease

Rachelle S. Doody, M.D.,Ph.D. Effie Marie Cain Chair in Alzheimer's Disease Research Director, Alzheimer's Disease and Memory Disorders Center Baylor College of Medicine-Department of Neurology Houston, Texas 77030: MedicalResearch.com MedicalResearch.com Interview with:
Rachelle S. Doody, M.D.,Ph.D.
Effie Marie Cain Chair in Alzheimer’s Disease Research
Director, Alzheimer’s Disease and Memory Disorders Center
Baylor College of Medicine-Department of Neurology
Houston, Texas 77030: MedicalResearch.com

MedicalResearch.com: What are the main findings of the study? 

Dr. Doody: The study set out to see whether the antibody infusion treatment, Solanezumab, would improve the course of mild to moderate Alzheimer’s disease in the ways necessary to gain drug approval.  Unfortunately, the results did not support an approvable treatment for this purpose.
MedicalResearch.com:  Were any of the findings unexpected? 

Dr. Doody:  In a number of analyses looked at using the data from these studies, there was a suggestion that the treatment might have been helpful for the milder patients.  This is not definitive since the studies were not designed to specifically assess the mild patients and since the benefits were not seen on every measurement used to evaluate the memory, thinking and functioning difficulties experienced by these patients.

MedicalResearch.com: What should clinicians and patients take away from your report? 

Dr. Doody: This monoclonal antibody therapy which reduces amyloid in animals that are engineered to accumulate amyloid (like Alzheimer’s disease patients) is now in studies of mild Alzheimer’s disease and in studies of normal people who have too much amyloid in their brains based, in part, on the results of these studies.

Citation:

Phase 3 Trials of Solanezumab for Mild-to-Moderate Alzheimer’s Disease

Rachelle S. Doody, M.D., Ph.D., Ronald G. Thomas, Ph.D., Martin Farlow, M.D., Takeshi Iwatsubo, M.D., Ph.D., Bruno Vellas, M.D., Steven Joffe, M.D., M.P.H., Karl Kieburtz, M.D., M.P.H., Rema Raman, Ph.D., Xiaoying Sun, M.S., Paul S. Aisen, M.D., Eric Siemers, M.D., Hong Liu-Seifert, Ph.D., and Richard Mohs, Ph.D. for the Alzheimer’s Disease Cooperative Study Steering Committee and the Solanezumab Study Group

N Engl J Med 2014; 370:311-321January 23, 2014DOI: 10.1056/NEJMoa1312889

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