Alzheimer Drug Aducanumab Appropriate-Use Recommendations Published 

Appropriate use recommendations for the newly approved Alzheimer disease treatment, aducanumab (Aduhelm; Biogen, Cambridge, MA) have been published in The Journal of Prevention of Alzheimer’s Disease (JPAD). These recommendations are authored by a panel of Alzheimer disease and dementia experts and provide guidance for whom should have this treatment and at what dose. The recommendations include: 

• Appropriate patient selection: use of aducanumab should be restricted to the population in whom efficacy and safety have been studied — those with mild cognitive impairment (MCI) due to AD and mild AD dementia with confirmed brain amyloid or cerebrospinal fluid findings consistent with AD; 
• Treatment management — aducanumab should be titrated over a 6-month period to the highest dose (10 mg/kg);
• Safety monitoring — brain MRI should be obtained before starting aducanumab, during titration, and at any time there are symptoms suggestive of amyloid-related imaging abnormalities; and
• Patient engagement —use of aducanumab should be in the context of patient-centered informed decision-making that includes comprehensive discussions and clear communication with patient and care partner(s) regarding the requirements for therapy, the expected outcome of therapy, potential risks and side effects, and the required safety monitoring, as well as uncertainties regarding individual responses and benefits. 

“The Alzheimer’s Association’s June 21 dialogue session, ‘Current Perspectives on Aducanumab,’ highlighted the urgent need for a consensus protocol for clinicians around the country,” said Maria C. Carrillo, PhD, Alzheimer’s Association chief science officer. “This is an important starting point, and this JPAD article, and the constructive response to it from the field, will be the basis for additional tools to educate and support clinicians, both primary care physicians and dementia specialists.”

Jeffrey Cummings, MD, ScD, Joy Chambers-Grundy Professor of Brain Science and director, Chambers-Grundy Center for Transformative Neuroscience, University of Nevada Las Vegas and one of the authors of the recommendations noted that the goal of the recommendations, "is to provide guidance for the safe and effective use of this new drug, in particular because aducanumab is an unprecedented therapy. It is the first drug approved for treatment of AD based on amyloid plaque removal, addressing the underlying biology of the disease.” Dr. Cummings is also a member of the Practical Neurology editorial board.

The published appropriate use guidance is based on the results of the pivotal trials (as presented publicly to the Food and Drug Administration [FDA]), the prescribing information for aducanumab, and the panel's expert consensus. In an accompanying commentary, written by Serge Gautier, MD and Pedro Rosa-Neto, MD, PhD, both of the McGill Center for Studies in Aging, Douglas Research Centre, Montreal, it is noted that the recommendations were written in the absence of peer-reviewed publication of the pivotal phase 3 trial results. When those data are published, it is possible that changes to appropriate-use recommendations may be needed.

The JPAD article was published simultaneously with a related session on Tuesday, July 27 at the Alzheimer’s Association International Conference 2021 called Implementation of Treatment to Practice.