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 |
| 1st 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 |
| 2nd 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. |
More detailed measures of outcomes are listed under each trail protocol in the relevant website
Abbreviations used in the table: ADAS-Cog-13 Score Alzheimer’s disease assessment scale- cognitive subscale score, ADCOMS Alzheimer’s disease composite score, ADCS-ADL Alzheimer’s disease cooperative study activities of daily living inventory instrumental items score, ADCS-PACC Score Alzheimer’s disease cooperative study preclinical alzheimer cognitive composite score, CDR Score change in clinical Dementia rating global score, CDR-SB Score the clinical Dementia rating - sum of boxes score, CFI cognitive function index, FAQ Score functional activities questionnaire score, MMSE Score mini-mental state examination score, NPI Score neuropsychiatric inventory score, Safety and tolerability by assessing adverse events (AEs) and serious adverse events (SAEs)