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Fig. 2 | Alzheimer's Research & Therapy

Fig. 2

From: A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody

Fig. 2

Randomization allocations by treatment group per protocol-defined interim analyses. The response adaptive randomization correctly allocated subjects into the dose groups likely to be ED90 doses (10 mg/kg monthly and biweekly) as early as the first interim analysis at 197 subjects, with both emerging by the 300th subject randomized, and these doses remained the most likely doses to demonstrate efficacy throughout the remainder of the study. However, before the interim analysis of 350 subjects, Health Authorities restricted randomization around ApoE4 carrier status, whereby ApoE4 carriers (hetero- or homozygous) were not to be randomized to the 10 mg/kg biweekly dose going forward. As a consequence, the response adaptive randomization algorithm was revised. After each subsequent interim analysis (starting with 350 subjects randomized), the randomization probability vector was split between ApoE4 carrier and non-carrier strata to ensure no ApoE4 carriers were enrolled on the 10 mg/kg biweekly dose (more details in Appendix C). At the same time, the revised response adaptive randomization preserved the overall randomization probabilities

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