Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer’s disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial

Koh, Seong-Ho; Kwon, Hyuk Sung; Choi, Seong Hye; Jeong, Jee Hyang; Na, Hae Ri; Lee, Chan Nyoung; Yang, YoungSoon; Lee, Ae Young; Lee, Jae-Hong; Park, Kyung Won; Han, Hyun Jeong; Kim, Byeong C.; Park, Jin Se; Lee, Jee-Young; Kim, Sangjae; Lee, Kyu-Yong

doi:10.1186/s13195-021-00803-w

Alzheimer's Research & Therapy

Table 2 Effects of GV1001 on primary and secondary endpoints in FAS and PPS

From: Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer’s disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial

Variables	Week	LS mean of CFB (± SE) in FAS
		Placebo (group 1)	GV1001 0.56 mg (group 2)	P value	GV1001 1.12 mg (group 3)	P value
		n = 27	n = 26		n = 28
SIB	12	− 3.7 (1.4)	− 0.1 (1.5)	0.178	0.7 (1.4)*	0.030
SIB	24	− 6.9 (1.9)	− 2.1 (2.0)	0.097	− 0.3 (1.9)*	0.027
K-MMSE	12	− 0.0 (0.5)	− 0.8 (0.6)	0.215	0.2 (0.5)	0.858
K-MMSE	24	− 0.7 (0.6)	− 1.2 (0.6)	0.365	− 0.4 (0.6)	0.751
CDR-SOB	12	0.5 (0.2)	0.4 (0.2)	0.772	0.4 (0.2)	0.594
CDR-SOB	24	1.1 (0.3)	0.5 (0.3)	0.182	0.8 (0.3)	0.518
NPI	12	4.6 (2.6)	0.9 (2.6)	0.263	− 4.8 (2.4)*	0.018
NPI	24	− 1.6 (4.3)	3.5 (4.3)	0.419	− 2.1 (4.3)	0.792
GDS	12	− 0.1 (0.1)	0.0 (0.1)	0.203	− 0.1 (0.1)	0.664
GDS	24	− 0.1 (0.1)	0.0 (0.1)	0.075	− 0.1 (0.1)	0.476
ADCS-ADL	12	− 2.3 (0.8)	− 0.1 (0.8)	0.148	− 0.3 (0.7)	0.166
ADCS-ADL	24	− 4.0 (1.0)	− 2.4 (1.0)	0.451	− 2.7 (1.0)	0.420
Variables	Week	LS mean of CFB (± SE) in PPS
		Placebo (group 1)	GV1001 0.56 mg (group 2)	P value	GV1001 1.12 mg (group 3)	P value
		n = 26	n = 22		n = 25
SIB	12	− 4.0 (1.4)	0.4 (1.5)	0.123	1.0 (1.4)*	0.016
SIB	24	− 7.2 (1.9)	− 1.5 (2.0)	0.070	− 0.1 (1.9)*	0.018
K-MMSE	12	− 0.1 (0.5)	− 0.7 (0.6)	0.288	0.4 (0.6)	0.596
K-MMSE	24	− 0.7 (0.6)	− 1.1 (0.6)	0.446	− 0.2 (0.6)	0.575
CDR-SOB	12	0.5 (0.2)	0.4 (0.3)	0.829	0.4 (0.2)	0.739
CDR-SOB	24	1.1 (0.3)	0.4 (0.4)	0.183	0.8 (0.3)	0.602
NPI	12	4.6 (2.6)	1.0 (2.7)	0.296	− 5.1 (2.6)*	0.017
NPI	24	− 1.6 (4.3)	3.3 (4.4)	0.456	− 2.2 (4.4)	0.818
GDS	12	− 0.1 (0.1)	0.0 (0.1)	0.209	− 0.1 (0.1)	0.948
GDS	24	− 0.1 (0.1)	0.0 (0.1)	0.073	− 0.1 (0.1)	0.733
ADCS-ADL	12	− 2.3 (0.8)	− 0.1 (0.9)	0.225	− 0.4 (0.8)	0.248
ADCS-ADL	24	− 4.0 (1.0)	− 2.4 (1.1)	0.516	− 2.7 (1.0)	0.470

P value for the differences between the treatment and placebo groups
The differences between the treatment group and placebo group were assessed using MMRM analysis
Abbreviations: FAS full analysis set, PPS per-protocol set, LS least square, CFB change from baseline, SE standard error, SIB Severe Impairment Battery, K-MMSE Korean Mini-Mental State Examination, CDR-SOB Clinical Dementia Rating Scale-Sum of Boxes, NPI Neuropsychiatric Inventory, GDS Global Deterioration Scale, ADCS-ADL Alzheimer’s Disease Cooperative Study-Activities of Daily Living, MMRM Mixed-effects Model Repeated Measures
*P < 0.05

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