Efficacy and safety of the novel GlyT1 inhibitor BI 425809 in Alzheimer’s dementia: a randomized controlled trial

Table 6 ADCS-ADL total scores and CIBIC+ scores at week 12: ANCOVA treatment comparison

	N	Adjusted mean change from baseline	SE	95% CI		Adjusted mean difference vs placebo	SE	95% CI
	N	Adjusted mean change from baseline	SE	Lower	Upper	Adjusted mean difference vs placebo	SE	Lower	Upper
ADCS-ADL^a
BI 425809 2 mg QD	113	0.29	0.54	− 0.77	1.34	0.02	0.76	− 1.48	1.52
BI 425809 5 mg QD	111	0.76	0.54	− 0.31	1.82	0.49	0.77	− 1.01	2.00
BI 425809 10 mg QD	110	− 1.26	0.54	− 2.33	− 0.19	− 1.53	0.77	− 3.04	− 0.02
BI 425809 25 mg QD	116	− 1.90	0.53	− 2.94	− 0.86	− 2.16	0.76	− 3.65	− 0.67
Placebo QD	111	0.27	0.54	− 0.80	1.33	.	.	.	.
CIBIC+^b	N	Adjusted mean	SE	95% CI		Adjusted mean difference vs placebo	SE	95% CI
CIBIC+^b	N	Adjusted mean	SE	Lower	Upper	Adjusted mean difference vs placebo	SE	Lower	Upper
BI 425809 2 mg QD	114	4.05	0.08	3.90	4.20	− 0.10	0.11	− 0.32	0.11
BI 425809 5 mg QD	112	4.10	0.08	3.95	4.25	− 0.05	0.11	− 0.26	0.16
BI 425809 10 mg QD	110	4.23	0.08	4.08	4.38	0.08	0.11	− 0.13	0.30
BI 425809 25 mg QD	116	4.26	0.08	4.10	4.41	0.10	0.11	− 0.11	0.32
Placebo QD	112	4.15	0.08	4.00	4.30	.	.	.	.

ADCS-ADL Alzheimer’s Disease Cooperative Study/Activities of Daily Living, ANCOVA analysis of covariance, CI confidence interval, CIBIC+ Clinician’s Interview-Based Impression of Change, CIBIS Clinical Interview-Based Impression of Severity, MMSE Mini-Mental State Examination, QD once daily, SE standard error
^aThe dependent variable was the change from the baseline score at week 12 in ADCS-ADL total score. The model includes fixed, categorical factors of planned treatment and baseline MMSE stratification factor (≥ 20, < 20), as well as fixed continuous covariate of baseline ADCS-ADL score
^bThe dependent variable was the CIBIC+ score at week 12. The model includes fixed, categorical factors of planned treatment and baseline MMSE stratification factor (≥ 20, < 20), as well as fixed continuous covariate of CIBIS score

ISSN: 1758-9193