Avoiding future controversies in the Alzheimer’s disease space through understanding the aducanumab data and FDA review

Table 1 Study 302: treatment effect at week 78, with and without post-ARIA observations excluded

	ITT population			ITT population excluding post-ARIA observations
	Placebo	Difference vs. Placebo (%)		Placebo	Difference vs. Placebo (%)
	Decline	Low dose	High dose	Decline	Low dose	High dose
	N = 548	N = 543	N = 547	N = 548	N = 543	N = 547
	n = 288	n = 290	n = 299	n = 254	n = 194	n = 172
CDR-SB	1.74	− 0.26 (− 15%)	− 0.39 (− 22%)	1.72	− 0.19 (− 11%)	− 0.57 (− 33%)
MMSE	− 3.3	− 0.1 (3%)	0.6 (− 18%)	− 3.4	− 0.1 (3%)	0.8 (− 24%)
ADAS-Cog 13	5.162	− 0.701 (− 14%)	− 1.400 (− 27%)	5.306	− 0.628 (− 12%)	− 2.193 (− 41%)
ADCS-ADL-MCI	− 4.3	0.7 (− 16%)	1.7 (− 40%)	− 4.3	0.5 (− 12%)	2.6 (− 60%)

N number of randomized and dosed patients that were included in the analysis, n number of randomized and dosed patients with primary endpoint assessment at week 78
Data source: 5.3.5.3 ISE_Final Table 33 and Appendix F Table 128, Table 129, and Table 130

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