Table 1 BACE1 inhibitors in clinical trials

Drug

MK-8931

JNJ-54861911

AZD-3293

E2609

CNP520

Sponsor

Merck

Janssen, Shionogi Pharma

AstraZeneca, Eli Lilly

Eisai, Biogen

Novartis, Amgen

Trial # (Phase)

NCT01739348 (II/III)

NCT02406027 (II)

NCT02245737 (II/III)

NCT02322021 (II)

NCT02576639 (II)

NCT01953601 (II/III)

NCT02406027 (II)

NCT02565511 (II/III)

NCT02569398 (II/III)

Dose

12, 40 or 60 mg

10, 25 or 50 mg

20 or 50 mg

25, 50, 100 and 200 mg

1, 10, 25 and 75 mg

Trial duration

78, 104 and 260 weeks

26, 52 or 96 weeks or 54 months

97 or 104 weeks

18 months

13 weeks and 5 years

1^st Outcomes

Baseline change in ADAS-Cog and ADCS-ADL scores

Safety measure by AEs or SAEs up to 10 months; Baseline change in ADCS-PACC Score (54 weeks),

Baseline change in CDR-SB Score

Baseline change in ADCOMS, Safety measure by AEs or SAEs

Safety measure by AEs or SAEs

2^nd Outcomes

Baseline change in CDR-SB score; CSF tau, brain amyloid load, NPI score, hippocampal volume, MMSE, score, etc.

Baseline change in CSF and plasma Aβ37, Aβ38, Aβ40, Aβ42, sAPPα, sAPPβ, Tau; CFI; CDR-SB, Neurodegeneration by Assessing Changes in Imaging Biomarkers, etc.

Baseline change in ADAS-Cog-13 score; CSF Aβ40, Aβ42, Tau; brain amyloid load by PET imaging, while brain volume, NPI score; ADCS-ADL score, etc.

volumetric Magnetic Resonance Imaging; Baseline change in CSF and plasma Aβ1-x, etc.

Baseline change in CDR-SB score; CSF Aβ40, Aβ42, total tau and phosphorylated tau, volumetric MRI; Everyday Cognition scale, etc.