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Fig. 4 | Alzheimer's Research & Therapy

Fig. 4

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. 4

Efficacy assessments. a Change from baseline for 10 mg/kg biweekly and monthly doses in the Alzheimer’s Disease Composite Score (ADCOMS). The MMRM used treatment group, visit, clinical subgroup (MCI due to AD, Mild AD), the presence or absence of ongoing AD treatment at baseline, ApoE4 status (positive, negative), region, treatment group-by-visit interaction as factors, and baseline value as covariate. *P < 0.05 (nominal). The primary analysis conducted at month 12 of treatment for all subjects indicated that the 10 mg/kg biweekly dose had a 64% probability to be better than placebo by 25% on ADCOMS at 12 months, missing the pre-specified 80% probability threshold for success. Bayesian analysis at 18 months determined that the lecanemab 10 mg/kg biweekly dose had a 76% probability of being better than placebo by 25% on ADCOMS. In addition, Bayesian analyses indicated a 98% probability of being superior to placebo by any magnitude at both 12 and 18 months, respectively, which is consistent with subsequent conventional analysis results. b Results for 10 mg/kg biweekly and monthly doses on CDR-SB. The number of subjects that were assessed at each time point are indicated in the table. The MMRM used treatment group, visit, clinical subgroup (MCI due to AD, Mild AD), the presence or absence of ongoing AD treatment at baseline, ApoE4 status (positive, negative), region, treatment group-by-visit interaction as factors, and baseline value as covariate. *P < 0.05 (nominal). c Results for 10 mg/kg biweekly and monthly doses on ADAS-Cog14. The number of subjects that were assessed at each time point are indicated in the table. The MMRM used treatment group, visit, clinical subgroup (MCI due to AD, Mild AD), the presence or absence of ongoing AD treatment at baseline, ApoE4 status (positive, negative), region, treatment group-by-visit interaction as factors, and baseline value as covariate. *P < 0.05 (nominal)

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