Aligning Patient, Clinician, and Caregiver Goals in Alzheimer Disease: Sharon Cohen, MD, FRCPC

WATCH TIME: 3 minutes

"There are 3 parties here. The clinician needs to know, is this treatment doing any good? Is the risk/benefit making sense? Patients want to stay as stable as possible, and of course improve if we can. But even if we’re keeping people mild longer, that’s a worthwhile goal that I think all 3 parties would buy into."

Headlined by little regulatory success, much of the discussion within the Alzheimer disease (AD) drug development space has been around using correct measures and biomarkers to establish an optimal treatment effect. Biogen’s antiamyloid agent aducanumab (Aduhelm) only exasperated that conversation further last summer when it became the first FDA-approved medication for the disease since 2003. Although it showed an impact on reduction of amyloid plaques, some questioned whether its efficacy is legitimate enough to have warranted approval.

Shortly after its approval, the FDA updated the label for aducanumab to treat patients with mild cognitive impairment or mild dementia stages of the disease, the population in which the treatment was initiated in clinical trials.¹ In a new item-level analysis of the phase 3 EMERGE study (NCT02484547), aducanumab’s treatment effects were observed across all Clinical Dementia Rating-Sum of Boxes domains, the primary end point. Additionally, it showed slowing of decline in AD Assessment Scale-Cognitive Subscale 13 items and preservation of daily function across the AD Cooperative Study–Activities of Daily Living (ADCS-ADL)-MCI scores.²

Lead investigator Sharon Cohen, MD, FRCPC, and colleagues concluded that the measures used reflect the perspectives of patients, caregivers, and clinicians, and presented these data at the2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, Washington. Cohen, a neurologist and assistant professor at the University of Toronto, sat down with NeurologyLive^® to discuss the shared goals between these groups and the top priorities. She stressed the need to hear all perspectives, including caregivers, as those conversations may have a direct impact on the management of the disease.

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REFERENCES
1. FDA approves updated Aduhelm prescribing information to emphasize population studied in clinical trials. News release. Biogen. July 8, 2021. Accessed April 25, 2022. https://www.eisai.com/news/2021/pdf/enews202156pdf.pdf

2. Cohen S, He P, Benea ML, et al. Item-level analysis of clinical measures in patients with early symptomatic Alzheimer’s disease following treatment with high-dose aducanumab in the phase 3 EMERGE study. Presented at: 2022 AAN Annual Meeting; April 2-7; Seattle, Washington. Poster 1386