Reasons for Selecting Certain Outcome Measures in Aducanumab’s Drug Development: Sharon Cohen, MD, FRCPC

WATCH TIME: 3 minutes

The conversations on Biogen’s antiamyloid therapy aducanumab (Aduhelm) have centered around the legitimacy of data and whether they can continue to prove its benefit in subsequent studies. One new analysis, presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, Washington, took a different approach, focusing in on changes from baseline item-level scores in primary, secondary, and tertiary end points.

In the item-level analysis of the pivotal EMERGE study (NCT02484547), one of the two phase 3 trials evaluating aducanumab in patients with early AD, the primary end point was change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) at week 78. Other secondary outcome measures included Mini-Mental State Examination, AD Assessment Scale–Subscale 13 items (ADAS-Cog13), and AD Cooperative Study–Activities of Daily Living (ADCS-ADL)-Mild Cognitive Impairment scores. Additionally, Neuropsychiatric Inventory 10-item NPI-10 scores were a tertiary outcome.

The analyses demonstrated consistency across cognitive, functional, and behavioral domains sensitive to impairments that are detectable, even in early AD. To learn more about the reasons for conducting the study as such, NeurologyLive^® sat down withlead investigator Sharon Cohen, MD, FRCPC. Cohen, a neurologist and assistant professor at the University of Toronto, discussed why it’s important to match outcome measures by the level of the patient population, and how if not done properly, it may lead to inaccurate data on treatment effects.

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REFERENCE
1. 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