ABT-126 monotherapy in mild-to-moderate Alzheimer’s dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension

Gault, Laura M.; Lenz, Robert A.; Ritchie, Craig W.; Meier, Andreas; Othman, Ahmed A.; Tang, Qi; Berry, Scott; Pritchett, Yili; Robieson, Weining Z.

doi:10.1186/s13195-016-0210-1

Alzheimer's Research & Therapy

Table 2 Double-blind secondary efficacy: change from baseline to final analysis from repeated-measures analyses

From: ABT-126 monotherapy in mild-to-moderate Alzheimer’s dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension

	Baseline		Week 24, n	Change from BL to week 24		Difference from placebo
	n	Observed mean (SD)	Week 24, n	Mean (SD)	LS mean ± SE	LS mean ± SE	90 % CI	P value
Alzheimer’s Disease Assessment Scale—Cognitive subscale, 13-item total score (↓ indicates improvement)
Placebo	98	38.26 (12.66)	88	−0.76 (6.99)	−0.67 ± 0.71
ABT-126 25 mg	71	35.05 (13.06)	63	−1.41 (6.82)	−1.14 ± 0.84	−0.47 ± 1.08	−2.25, 1.31	0.333
ABT-126 50 mg	100	36.71 (12.52)	87	−2.12 (6.41)	−1.70 ± 0.71	−1.03 ± 0.98	−2.65, 0.60	0.149
ABT-126 75 mg	68	39.11 (10.72)	61	−2.32 (6.07)	−1.87 ± 0.84	−1.19 ± 1.09	−2.98, 0.60	0.137
Donepezil	68	39.18 (14.13)	59	−3.56 (6.69)	−3.54 ± 0.87	−2.86 ± 1.10	−4.67, −1.05	0.005*
Mini-Mental Status Examination score (↑ indicates improvement)
Placebo	98	18.97 (4.01)	89	0.56 (2.83)	0.39 ± 0.32
ABT-126 25 mg	72	20.08 (4.04)	64	0.19 (3.13)	−0.16 ± 0.38	−0.55 ± 0.49	−1.36, 0.27	0.866
ABT-126 50 mg	102	18.70 (3.92)	92	0.86 (3.38)	0.78 ± 0.32	0.39 ± 0.44	−0.34, 1.12	0.191
ABT-126 75 mg	69	18.39 (3.88)	62	0.74 (3.17)	0.53 ± 0.38	0.14 ± 0.49	−0.68, 0.95	0.390
Donepezil	69	18.59 (4.42)	59	1.29 (2.76)	1.19 ± 0.39	0.80 ± 0.50	−0.02, 1.62	0.055
Clinician Interview-Based Impression of Severity and Clinician Interview-Based Impression of Change—Plus^a
Placebo	98	3.64 (0.79)	89	4.15 (0.83)	4.18 ± 0.09
ABT-126 25 mg	73	3.77 (0.86)	64	4.03 (0.73)	4.06 ± 0.10	−0.12 ± 0.13	−0.33, 0.10	0.184
ABT-126 50 mg	102	3.63 (0.87)	92	3.95 (0.87)	4.03 ± 0.08	−0.15 ± 0.12	−0.34, 0.05	0.105
ABT-126 75 mg	68	3.75 (0.82)	61	3.77 (0.84)	3.80 ± 0.10	−0.38 ± 0.13	−0.59, −0.16	0.002*
Donepezil	69	3.88 (0.81)	59	3.68 (0.78)	3.75 ± 0.10	−0.43 ± 0.13	−0.65, −0.21	<0.001*
Neuropsychiatric Inventory, 10-item total score (↓ indicates improvement)
Placebo	98	8.64 (8.70)	89	0.18 (6.27)	−0.26 ± 0.82
ABT-126 25 mg	73	9.21 (8.93)	64	−1.72 (7.81)	−1.09 ± 0.96	−0.82 ± 1.23	−2.86, 1.21	0.252
ABT-126 50 mg	102	8.30 (8.07)	93	−0.59 (9.78)	−0.50 ± 0.81	−0.24 ± 1.11	−2.07, 1.60	0.416
ABT-126 75 mg	69	10.57 (11.31)	62	−0.98 (7.26)	−0.13 ± 0.96	0.14 ± 1.25	−1.92, 2.19	0.544
Donepezil	69	12.39 (11.63)	59	−3.27 (9.87)	−2.72 ± 0.99	−2.45 ± 1.26	−4.53, −0.38	0.026*
Neuropsychiatric Inventory, 12-item total score (↓ indicates improvement)
Placebo	98	10.17 (9.66)	89	0.30 (7.67)	−0.11 ± 0.95
ABT-126 25 mg	73	11.19 (10.45)	64	−1.91 (9.84)	−0.92 ± 1.11	−0.81 ± 1.44	−3.17, 1.56	0.287
ABT-126 50 mg	102	9.43 (8.55)	93	−0.03 (11.12)	0.05 ± 0.94	0.16 ± 1.30	−1.98, 2.30	0.549
ABT-126 75 mg	69	12.19 (12.93)	62	−1.52 (8.01)	−0.54 ± 1.12	−0.43 ± 1.45	−2.82, 1.96	0.383
Donepezil	69	13.41 (12.77)	59	−3.10 (10.82)	−2.67 ± 1.15	−2.55 ± 1.46	−4.96, −0.15	0.041*
Alzheimer’s Disease Cooperative Study—Activity of Daily Living total score (↑ indicates improvement)
Placebo	98	56.46 (14.17)	89	−1.79 (8.16)	−2.30 ± 0.76
ABT-126 25 mg	73	57.15 (16.35)	64	0.28 (6.65)	−0.44 ± 0.89	1.86 ± 1.14	−0.03, 3.74	0.053
ABT-126 50 mg	102	55.97 (14.96)	93	0.18 (7.13)	0.00 ± 0.75	2.30 ± 1.04	0.60, 4.01	0.013*
ABT-126 75 mg	69	54.30 (14.65)	62	−0.21 (7.18)	−0.44 ± 0.90	1.86 ± 1.15	−0.04, 3.76	0.054
Donepezil	69	52.00 (14.11)	59	2.14 (5.60)	1.71 ± 0.92	4.01 ± 1.16	2.09, 5.93	<0.001*
	Baseline		Week 18, n	Change from BL to week 18		Difference from placebo
	n	Observed mean (SD)	Week 18, n	Mean (SD)	LS mean ± SE	LS mean ± SE	90 % CI	P value
Wechsler Memory Scale—III Working Memory Index total score (↑ indicates improvement)
Placebo	93	74.02 (13.28)	91	2.04 (11.21)	1.17 ± 1.11
ABT-126 25 mg	68	78.50 (17.02)	65	0.83 (11.38)	0.24 ± 1.31	−0.93 ± 1.64	−3.63, 1.77	0.715
ABT-126 50 mg	99	75.57 (13.40)	93	−0.42 (11.32)	−1.73 ± 1.10	−2.91 ± 1.48	−5.34, −0.47	0.975
ABT-126 75 mg	66	77.85 (15.40)	64	−1.66 (10.66)	−2.34 ± 1.27	−3.52 ± 1.65	−6.23, −0.80	0.983
Donepezil	61	75.66 (15.54)	61	1.82 (8.88)	1.31 ± 1.35	0.13 ± 1.65	−2.60, 2.86	0.468

^*One-sided P value statistically significant vs placebo
^aClinician Interview-Based Impression of Severity at baseline and Clinician Interview-Based Impression of Change—Plus at subsequent visits. Clinician Interview-Based Impression of Change—Plus ratings range from 1 = markedly improved to 7 = markedly worse. LS means (SE) are presented instead of LS mean (SE) of change
BL baseline (last assessment taken on or before the day –1 visit), LS least squares, SD standard deviation, SE standard error

Back to article page

ISSN: 1758-9193

Contact us

General enquiries: journalsubmissions@springernature.com