Additional file 1: of Pharmacodynamics of atabecestat (JNJ-54861911), an oral BACE1 inhibitor in patients with early Alzheimer’s disease: randomized, double-blind, placebo-controlled study

Figure S1. Four-step screening process targeting biomarker-positive patients either as preclinical AD (CDR = 0) or with MCI due to AD (CDR = 0.5). Figure S2. Schematic of atabecestat (JNJ-54861911) population PK model and PK/PD model of CSF Aβ1–40. Figure S3. Consolidated Standards of Reporting Trials (CONSORT) diagram. Figure S4. Percent changes from baseline in CSF Aβ fragments (Aβ1–37, Aβ1–38, Aβ1–40, Aβ1–42) levels at day 28 for Caucasian (a) and Japanese (b) patients across atabecestat (JNJ-54861911) dose groups. Figure S5. Percent changes from baseline in CSF total sAPP level and sAPP-α and sAPP-β fragments at day 28 for Caucasian (a) and Japanese (b) patients across atabecestat (JNJ-54861911) dose groups. Figure S6. Percent changes from baseline in CSF BACE protein level at day 28 for Caucasian patients with early AD across atabecestat (JNJ-54861911) dose groups. Figure S7. Scatterplot of CSF Aβ1–40 reduction vs. CSF concentration of atabecestat (JNJ-54861911) after administration of 10- and 50-mg doses in Japanese preclinical AD (day 28, Study ALZ1008). Table S1. Atabecestat (JNJ-54861911) plasma and CSF pharmacokinetic parameters. Table S2. Percent reductions from baseline in CSF Aβ levels by APOE ε4 subgroups for early AD Caucasian population. Table S3. Summary of change from baseline in cognitive outcome measurements for early AD Caucasian population. Table S4. Incidence of treatment-emergent adverse events by body system, preferred term, and atabecestat (JNJ-54861911) treatment group for Caucasian ALZ1005 population (safety analysis set). (DOCX 374 kb