Following FDA approval of aducanumab in early June, a small panel of experts on Alzheimer's disease (AD) have developed clinical use recommendations for the anti-amyloid drug in the US. The recommendations were published in the Journal of Prevention of Alzheimer's disease, and presented at the 2021 Alzheimer's Association International Conference (AAIC).
During their presentation at the AAIC, Prof. Jeffrey Cummings and colleagues on the expert panel explained that aducanumab should only be prescribed to adults with mild cognitive impairment linked to AD and early AD dementia, as these were the groups that were studied in the aducanumab clinical trials.
The expert panel recommended that patients receiving aducanumab should follow a similar treatment course to participants in the clinical trials, with gradual titration up to the 10mg/kg dose over a period of 6 months, as well as regular monitoring via MRI scans during first year of treatment. Additional MRI scans should be carried out if patients being treated with aducanumab experience any symptoms of amyloid-related imaging abnormalities (ARIA - a well-known side-effect of aducanumab), and treatment should be halted in patients with symptomatic, MRI-confirmed ARIA, as well as those with non-symptomatic, but moderate or severe ARIA.
The expert panel emphasised the importance of patient-centred and informed decision-making, involving care partners where relevant. They recommended that discussions should cover the potential risks as well as the benefits of aducanumab, the safety monitoring required, and the utility of APOE4 genetic testing to identify whether patients may be at greater risk of severe ARIA.
The panel also noted that the effective deployment of aducanumab treatment would require substantial infrastructure for appropriate administration, including experts in early AD diagnosis; facilities to perform and interpret brain imaging scans and lumbar punctures; and infusion centres for aducanumab administration.
The recommendations can be accessed via this link:
