A randomized, double-blind, placebo-controlled phase II trial to explore the effects of a GABAA-α5 NAM (basmisanil) on intellectual disability associated with Down syndrome

Table 2 Change from baseline scores at 3 and 6 months

Assessment	Time point (month)	Placebo		120 (80) mg			240 (160) mg
Assessment	Time point (month)	Mean ± SD	n	Mean ± SD	n	p	Mean ± SD	n	p
RBANS
List learning	3	1.5 ± 5.2	54	2.3 ± 5.4	47	0.69	1.0 ± 5.12	48	0.86
List learning	6	3.1 ± 6.1	51	2.7 ± 6.2	47	0.56	2.4 ± 4.8	44	0.76
List recall	3	0.5 ± 2.8	53	0.2 ± 2.2	47	0.49	0.4 ± 2.5	48	0.98
List recall	6	0.3 ± 2.4	51	0.2 ± 3.1	47	0.98	-0.1 ± 2.4	44	0.83
List recognition	3	0.0 ± 2.9	53	1.1 ± 2.3	47	0.09	0.8 ± 4.2	48	0.26
List recognition	6	1.2 ± 3.2	51	1.4 ± 3.1	47	0.75	1.8 ± 3.9	44	0.29
VABS-II
Composite score	3	1.6 ± 5.0	53	0.98 ± 4.6	46	0.60	1.02 ± 3.7	47	0.62
Composite score	6	2.4 ± 10.2	50	2.0 ± 4.02	46	0.79	2.02 ± 4.6	43	0.72
CELF-4 (word classes 1)
Receptive	3	− 0.2 ± 3.7	54	− 0.5 ± 4.1	47	0.74	1.1 ± 2.8	48	0.09
Receptive	6	0.8 ± 3.6	51	− 0.07 ± 3.4	46	0.28	1.5 ± 3.6	44	0.31
Expressive	3	0.5 ± 3.8	54	0.6 ± 3.9	47	0.79	1.2 ± 3.2	48	0.22
Expressive	6	0.9 ± 3.1	51	0.3 ± 3.8	46	0.34	1.3 ± 3.1	44	0.54
CELF-4 (word classes 2)
Receptive	3	0.1 ± 2.1	51	− 0.2 ± 2.0	43	0.23	0.0 ± 2.1	43	0.60
Receptive	6	− 0.3 ± 3.6	47	0.0 ± 3.1	41	0.99	0.2 ± 2.3	40	0.52
Expressive	3	0.2 ± 1.5	51	− 0.07 ± 1.1	43	0.14	0.2 ± 1.5	43	0.99
Expressive	6	0.1 ± 2.4	47	− 0.07 ± 1.4	41	0.41	0.2 ± 1.6	40	0.78
BRIEF-P^a
Global executive composite	3	− 4.1 ± 12.3	53	− 6.6 ± 12.7	47	0.48	− 5.2 ± 11.6	48	0.75
Global executive composite	6	− 4.1 ± 12.2	51	− 7.8 ± 12.6	46	0.16	− 7.9 ± 12.7	42	0.10
PedsQL
Total scale score	3	0.9 ± 14.0	54	2.7 ± 15.3	48	0.75	3.9 ± 12.1	45	0.19
Total scale score	6	1.7 ± 12.7	47	5.6 ± 12.5	46	0.31	3.5 ± 9.7	41	0.46

See Additional file 12 for “change from baseline” scores by age group and time point
Abbreviations: BRIEF-P Behavior Rating Inventory of Executive Function-Preschool, CELF Clinical Evaluation of Language Fundamentals, PedsQL Pediatric Quality of Life Inventory, RBANS Repeatable Battery for the Assessment of Neuropsychological Status, SD standard deviation, VABS-II Vineland Adaptive Behavior Scales-II
^aNegative change = improvement

ISSN: 1866-1955