LAS VEGAS – July 27, 2021 – A group of six leading Alzheimer’s experts has presented the first recommendations for the appropriate use of aducanumab (Aduhelm, Biogen/Eisai), a newly approved treatment for early Alzheimer’s disease (AD). The recommendations will help provide clinicians with greater clarity and more specific use of the new treatment, which was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in June.
The recommendations were presented today at the annual Alzheimer’s Association International Conference (AAIC) and were simultaneously published in a special article of The Journal of Prevention of Alzheimer’s Disease (JPAD) and in Alzheimer’s & Dementia®: The Journal of The Alzheimer’s Association. Stephen Salloway, MD, MS, director of Neurology and the Memory and Aging Program at Butler Hospital, the Martin M. Zucker professor of Psychiatry and Human Behavior and professor of Neurology at the Warren Alpert Medical School of Brown University, and associate director of Brown University’s Center for Alzheimer’s Research, was among the panel of experts and co-authored the article.
University of Nevada, Las Vegas neuroscientist Dr. Jeffrey Cummings co-chaired the expert panel presentation at AAIC along with Alzheimer’s Association Chief Science Officer Maria C. Carrillo, Ph.D., and co-authored the JPAD article along with Dr. Salloway.
“Many details of the clinical use of this new agent are not in the FDA’s prescribing information,” Cummings said. “These recommendations fill the gap between the prescribing information and the real-world implementation of this treatment.”
“The recommendations made by this expert panel today and in the JPAD article mirror the guidelines used during the clinical trial of aducanumab,” Dr. Salloway said. “Our goal is to guide clinicians on the selection of patients most likely to benefit from treatment with recommendations on how to carefully monitor for safety. The evidence we have is that patients with early Alzheimer’s disease, mild cognitive impairment or mild dementia with confirmed amyloid build-up, are most likely to benefit and we will need close collaboration between primary care and specialty providers to identify these patients.”
The appropriate use recommendations made by the panel include a list of 11 factors that they say should be satisfied for a patient to be considered eligible for treatment with Aduhelm. Those factors include, in part: a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild stage AD dementia after a comprehensive evaluation; the presence of amyloid plaques in the brain as demonstrated on PET imaging or by AD signature pattern on cerebrospinal fluid (CSF) testing; the attainment of certain specific cognitive assessment scores; stable psychiatric and medical conditions including stable cardiovascular and cardiopulmonary health, no organ failure or active cancer, no evidence of neurological disorders other than AD, and a baseline MRI with no evidence of acute or subacute hemorrhage, among other factors. The article containing the complete list of appropriate use criteria is available on the JPAD website at jpreventionalzheimer.com. The summary article from Alzheimer’s & Dementia® is also available at alz-journals.onlinelibrary.wiley.com.
In addition to Drs. Cummings and Salloway, the expert panel included: Paul Aisen, M.D., Alzheimer’s Treatment Research Institute, University of Southern California, San Diego, CA; Liana Apostolova, M.D., FAAN, Departments of Neurology, Radiology, Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN; Alireza Atri, M.D., Ph.D., Banner Sun Health Research Institute, Banner Health, Sun City, AZ; Center for Brain/Mind Medicine, Harvard Medical School, Boston, MA; and Michael Weiner, M.D. Departments of Radiology and Biomedical Imaging, Medicine, Psychiatry and Neurology, University of California San Francisco, San Francisco, CA.
Aduhelm is the first drug approved to lower amyloid plaques to help slow the progression of Alzheimer’s disease (AD) in people diagnosed with mild cognitive impairment (MCI) or early AD. Rhode Island contributed one of the largest number of participants enrolled in the clinical studies that led to Aduhelm’s approval, through study sites at Butler Hospital and Rhode Island Hospital, both of which are affiliates of the Warren Alpert Medical School of Brown University.
Eligibility criteria and other information for those interested in seeking treatment with Aduhelm at Butler Hospital is available at butler.org/memory, by calling the Memory and Aging Program at Butler Hospital at (401) 455-6402, or by e-mailing the program at firstname.lastname@example.org.
About Butler Hospital
Butler Hospital, a member of Care New England, is the only private, nonprofit psychiatric and substance abuse hospital serving adults, seniors and adolescents in Rhode Island and southeastern New England. Founded in 1844, it was the first hospital in Rhode Island and has earned a reputation as the leading provider of innovative psychiatric treatments in the region. The Major Affiliated Teaching Hospital for Psychiatry and Behavioral Health at The Warren Alpert Medical School of Brown University, Butler is recognized worldwide as a pioneer in conducting cutting-edge research.
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