Additional file 1 of A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody
Creators: name: Swanson, Chad J.
name: Zhang, Yong
name: Dhadda, Shobha
name: Wang, Jinping
name: Kaplow, June
name: Lai, Robert Y. K.
name: Lannfelt, Lars
name: Bradley, Heather
name: Rabe, Martin
name: Koyama, Akihiko
name: Reyderman, Larisa
name: Berry, Donald A.
name: Berry, Scott
name: Gordon, Robert
name: Kramer, Lynn D.
name: Cummings, Jeffrey L.
Publisher: name: figshare
Year: 2021
Subjects: subject: Medicine
subject: Cell Biology
subject: Neuroscience
subject: Pharmacology
subject: Immunology
subject: FOS: Clinical medicine
subject: Mental Health
subject: Virology

description: Additional file 1: Supplemental Figure S1. CONSORT 2010 Flow Diagram. Supplemental Figure S2. Change from Baseline for all Treatment Groups in the Alzheimer's Disease Composite Score (ADCOMS). Supplemental Figure S3. Results for ADAS-cog (3SA) and CDR-SB (3SB) for All Dosing groups. Supplemental Figure S4. Results for Total Hippocampal Volume (S4A), Whole Brain Volume (S4B), and Ventricular Volume for All Dosing Groups (S4C). Supplemental Figure S5. Change from Baseline in Neurogranin Measures (5SA). Change from Baseline in Neurofilament Light Chain Measures (5SB). Supplemental Table S1. Baseline Characteristics for Completers – Full Analysis Set. Supplemental Table S2. Baseline Characteristics for Subjects who Discontinued Treatment – Full Analysis Set. Supplemental Table S3. Bayesian Analysis of ADCOMS at 18 Months – Full Analysis Set. Supplemental Table S4. Summary of MMRM Analyses for Change from Baseline in ADCOMS at 12 Months – Full Analysis Set. Supplemental Table S5. Summary of MMRM Analyses for Change from Baseline in ADCOMS at 18 Months – Full Analysis Set. Supplemental Table S6. Bayesian Analysis of CDR-SB at 18 Months – Full Analysis Set. Supplemental Table S7. Summary of MMRM Analyses for Change from Baseline in CDR-SB at 18 Months – Full Analysis Set. Supplemental Table S8. Bayesian Analysis of ADAS-Cog14 at 18 Months – Full Analysis Set. Supplemental Table S9. Summary of MMRM Analyses for Change from Baseline in ADAS-Cog14 at 18 Months – Full Analysis Set. Supplemental Table S10. Summary of MMRM Analyses for ADCOMS at 18 Months for Disease Stage (MCI due to AD and Mild AD Dementia) Subgroups - Full Analysis Set. Supplemental Table S11. Summary of MMRM Analyses for ADAS–Cog14 at 18 Months for Disease Stage (MCI due to AD and Mild AD Dementia) – Full Analysis Set. Supplemental Table S12. Summary of MMRM Analyses for CDR-SB at 18 Months for Disease Stage (MCI due to AD and Mild AD Dementia) – Full Analysis Set. Supplemental Table S13. Summary of MMRM Analyses for Change from Baseline in Total Hippocampal Volume at 18 Months. Supplemental Table S14. Summary of MMRM Analyses for Change from Baseline in vMRI Whole Brain Volume at 18 Months – MMRM Pharmacodynamic Analysis Set. Supplemental Table S15. Summary of MMRM Analyses for Change from Baseline in vMRI Total Ventricular Volume at 18 Months – MMRM Pharmacodynamic Analysis Set. Supplemental Table S16. Bayesian Analysis of ADCOMS at 18 Months for ApoE4 Genotype (Carrier or Non-Carrier) Subgroups - Full Analysis Set. Supplemental Table S17. Sensitivity Analyses for Efficacy Assessments. Supplementary Appendix A. Study Protocol. Supplementary Appendix B. Simulation Plan. Supplementary Appendix C. Additional Detail on Cases of ARIA-E. Supplementary Appendix D. Principal Investigators from Participating Enrolling Centers.