An expert panel in the Alzheimer’s and dementia field has published the first recommendations for the appropriate use of aducanumab (Aduhelm™), recently granted accelerated approval for early Alzheimer’s disease — mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s dementia.
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The recommendations cover the appropriate population and dose for the drug, monitoring for side effects, and clinician communication with their patients and care partners:
- Appropriate Patient Selection — The pivotal trials included patients with early Alzheimer’s (mild cognitive impairment due to Alzheimer’s and mild Alzheimer’s dementia) who had confirmed brain amyloid using amyloid positron emission tomography or cerebrospinal fluid findings consistent with Alzheimer’s disease. The Expert Panel recommends that use of aducanumab be restricted to this population in which efficacy and safety have been studied.
- Treatment Management — Aducanumab is titrated to a dose of 10 mg/kg over a six-month period. The Expert Panel recommends that aducanumab be titrated to the highest dose to maximize the opportunity for efficacy.
- Safety Monitoring — Aducanumab can substantially increase the incidence of amyloid-related imaging abnormalities (ARIA) with brain effusion or hemorrhage. The Expert Panel recommends MRIs prior to initiating therapy, during the titration of the drug and anytime the patient has symptoms suggestive of ARIA.
- Patient Engagement —The Expert Panel emphasized the critical importance of engaging in patient-centered and informed decision-making. This should include comprehensive discussions and clear communication with the patient and care partner 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 dialogue session, “Current Perspectives on Aducanumab
,” hosted by the Alzheimer's Association on June 21, 2021, highlighted the urgent need for a consensus protocol for clinicians around the country.
The panel’s recommendations, as well as the constructive response to it from those working in the field of Alzheimer’s and dementia research, will be the basis for additional tools to educate and support both primary care clinicians and dementia specialists.
For more information, read the panel's recommendations, Aducanumab: Appropriate Use Recommendations, in The Journal of Prevention of Alzheimer's Disease (JPAD), or download as a PDF.
A summary of the recommendations is also available in Alzheimer's & Dementia, the journal of the Alzheimer's Association.