pISSN 1226-6051
eISSN 2508-786X

Table. 2.

Table. 2.

Summary of results from included clinical trials

Study Study drug Intervention Comparator Efficacy results Safety results
Budd 2022 17) [ENGAGE] aducanumab Low dose aducanumab (n=547)
(3 or 6 mg/kg)
High dose aducanumab (n=555)
(6 or 10 mg/kg)
Placebo(n=545) [ADAS-Cog 13] difference vs. placebo
Low dose (n=332) -0.583 (95% CI: -1.5835 to 0.4181), p=0.2536
High dose (n=294) -0.588 (95% CI: -1.6067 to 0.4309), p=0.2578 placebo (n=331)
[MMSE] difference vs. placebo
Low dose (n=334) 0.2 (95% CI: -0.35 to 0.74), p=0.4795
High dose (n=297) -0.1 (95% CI: -0.62 to 0.49), p=0.8106
placebo (n=332)
[Death] (PC Period)low dose: 3/549 (0.55%)
high dose: 2/558 (0.36%)
placebo: 5/540 (0.00%)[SAE]
low dose: 76/549 (13.8%)
high dose: 79/558 (14.2%)
placebo: 70/540 (12.96%)
Cohen 202116) (EMERGE) Aducanumab Drug: Aducanumab (BIIB037)
Low dose
Drug: Aducanumab (BIIB037)
High dose
Placebo [ADAS-Cog13] difference (95% CI)
Low Dose: n=289, -0.701 (-1.7649 to 0.3627), p=0.1962
High Dose: n=293, -1.400 (-2.4596 to -0.3396), p=0.0097
Placebo: n=287
[MMSE] difference (95% CI)
Low Dose: n=293, -0.1 (-0.65 to 0.48), p=0.7578
High Dose: n=299, 0.6 (0.00 to 1.13), p=0.0493
Placebo: n=288
[Death] (PC Period)
low dose: 0/544 (0.0%)
high dose: 6/547 (1.1%)
placebo: 5/547 (0.9%)
[SAE] (PC Period)
low dose: 72/544 (13.2%)
high dose: 73/547 (13.4%)
placebo: 81/547 (14.8%)
Hannestad 202129) GRF6019 GRF6019 (n=18)
placebo (n=8)
placebo MMSE change from baseline: total score (mean SD)
GRF6019 Evaluable Population (n=18): 1.3 (3.53)
Placebo (n=8): 1.8 (3.20)
[Death]
GRF6019: 0/18 (0.0%)
placebo: 0/8 (0.0%)
[SAE]
GRF6019: 0/18 (0.0%)
placebo: 0/8 (0.0%)
Koh 202130) GV1001 GV1001 0.56mg (n=33)
GV1001 1.12mg (n=32)
placebo (n=31) K-MMSE
LS mean of change from baseline ± SE (P-value) vs Placebo
placebo (n=27) -0.7±0.6
GV1001 0.56mg (n=26) -1.2±0.6 (0.365)
GV1001 1.12mg (n=28) -0.4±0.6 (0.751)
[SAE]
GV1001 0.56mg: 0/32 (0.0%)
GV1001 1.12mg: 0/32 (0.0%)
placebo: 2/31 (6.5%), p=0.104
Mintun 202118) Donanemab Donanemab 700mg (n=131) Placebo (n=126) ADAS-Cog13
difference donanemab vs placebo, change from baseline
-1.86 (95% CI,-3.63 to -0.09), p=0.040
MMSE
difference donanemab vs placebo, change from baseline
0.64 (95% CI, -0.40 to 1.67), p=0.227
[Death]
donanemab: 1/131 (0.8%)
placebo: 2/125 (1.6%)
[SAE]
donanemab: 26/131 (19.8%) placebo: 25/125 (20.0%)
Nirogi 202226) masupirdine masupirdine 50mg (n=190)
masupirdine 100mg (n=185)
placebo (n=189) ADAS-Cog11 difference vs placebo (95% CI) from baseline
masupirdine 50mg: -0.5 (-1.8, 0.7), p=0.41
masupirdine 100mg: -0.1 (-1.4, 1.2), p=0.90
MMSE difference vs placebo (95% CI) from baseline
masupirdine 50mg: -0.1 (-0.8, 0.6), p=0.79
masupirdine 100mg: 0.0 (-0.7, 0.7), p=0.92
[Death]
50mg: 3/187 (1.6%)
100mg: 2/181 (1.1%)
placebo: 1/188 (0.5%)
[SAE]
50mg: 10/187 (5.4%)
100mg: 14/181 (7.7%)
placebo: 12/188 (6.4%)
Ostrowitzki 202219) [CREAD] Crenezumab [CREAD]
Crenezumab 60 mg/kg (n = 409)
[CREAD2]
Crenezumab 60 mg/kg (n = 407)
[CREAD]
Placebo (n = 409)
[CREAD2]
Placebo (n = 399)
ADAS-Cog13, LS Mean difference (95% CI)
Placebo (n=86)
Crenezumab (n=80) -0.26 (-2.39 to 1.87), SE=1.083
MMSE, LS Mean difference (95% CI)
Placebo (n=90)
Crenezumab (n=87) 0.33 (-0.62 to 1.29), SE=0.486
[Death]
crenezumab: 8/404 (2.0%)
placebo: 5/405 (1.2%)
[SAE]
crenezumab: 67/404 (16.6%)
placebo: 63/405 (15.6%)
Ostrowitzki 202218) [CREAD2] Crenezumab [CREAD]
Crenezumab 60 mg/kg (n = 409)
[CREAD2]
Crenezumab 60 mg/kg (n = 407)
[CREAD]
Placebo (n = 409)
[CREAD2]
Placebo (n = 399)
ADAS-Cog13, LS Mean difference (95% CI)
Placebo (n=15)
Crenezumab (n=12) 1.74 (-2.40 to 5.89), SE=2.028
MMSE, LS Mean difference (95% CI)
Placebo (n=15)
Crenezumab (n=12) -0.41 (-2.42 to 1.60), SE=0.985
[Death]
crenezumab: 0/404 (0.0%)
placebo: 6/398 (1.5%)
[SAE]
crenezumab: 33/404 (8.2%)
placebo: 42/398 (10.6%)
Prins
202124) Neflamapimod Neflamapimod 40mg bid (n=78) placebo (n=83) [MMSE] means (95% CI)
placebo (n=79)
Neflamapimod (n=70) -0.3 (-1.0 to 0.5), p=0.489
[Death]
neflamapimod: 0/78 (0.0%)
placebo: 0/83 (0.0%)
[SAE]
neflamapimod: 2/78 (2.6%)
placebo: 3/83 (3.6%)
Sperling 202115) Atabecestat atabecestat 5 mg(n=189)
atabecestat 25 mg(n=183)
placebo(n=185) N/A [Death]
5mg: 0/189 (0.0%)
25mg: 0/183 (0.0%)
placebo: 0/185 (0.0%)
[SAE]
5mg: 18/189 (9.5%)
25mg: 26/183 (14.2%)
placebo: 9/185 (4.9%)
Swanson202120) Lecanemab Lecanemab 2.5 mg/kg biweekly (N =52)
Lecanemab 5 mg/kg monthly (N =51)
Lecanemab 5 mg/kg biweekly (N =92)
Lecanemab 10 mg/kg Monthly (N =253)
Lecanemab 10 mg/kg biweekly (N =161)
placebo (n=247) ADAS-Cog14 LS mean difference vs placebo (95% CI) [p-value]
2.5 mg/kg Biweekly (n=52) 0.672 (-1.586, 2.930) [0.624]
5 mg/kg Monthly (n=48) 0.844 (-1.422, 3.111) [0.539]
5 mg/kg Biweekly (n=89) -0.395 (-2.192, 1.401) [0.717]
10 mg/kg Monthly (n = 246) -0.278 (-1.635, 1.079) [0.736]
10 mg/kg Biweekly (n = 152) -2.313 (-3.910, -0.717) [0.017]
[Death]
2.5 mg/kg bw: 2/52 (3.8%)
5 mg/kg m: 0/51 (0.0%)
5 mg/kg bw: 1/92 (1.1%)
10 mg/kg m: 2/253 (0.8%)
10 mg/kg bw: 0/161 (0.0%)
placebo: 2/245 (0.8%)
[SAE]
2.5 mg/kg bw: 10/52 (19.2%)
5 mg/kg m: 4/51 (7.8%)
5 mg/kg bw: 16/92 (17.4%)
10 mg/kg m: 31/253 (12.3%)
10 mg/kg bw25/161 (15.5%)
placebo: 43/245 (17.6%)
Teng 202222) Semorinemab Semorinemab 1500mg (n=94)
Semorinemab 4500mg (n=136)
Semorinemab 8100mg (n=92)
placebo (n=135) Change from baseline on the ADAS-Cog13 Subscale: Mean (SE)
Placebo (n = 94) 6.56 (0.777)
Semorinemab 1500 mg (n = 67) 8.68(0.937)
Semorinemab 4500 mg (n = 97) 6(0.769)
Semorinemab 8100 mg (n = 66) 7.58(0.932)
[Death] (blind period)
1500 mg: 0/89 (0.0%)
4500 mg: 1/132 (0.8%)
8100 mg: 1/90 (1.1%)
placebo: 2/130 (1.5%)
[SAE] (blind period)
1500 mg: 17/89 (19.1%)
4500 mg: 17/132 (12.9%)
8100 mg: 16/90 (17.8%)
placebo: 14/130 (10.8%)
van Dyck 202321) Lecanemab Lecanemab 10mg/kg 10 mg every 2 weeks (n=898) placebo (n=897) [lecanemab (n=859), placebo (n=875)]
ADAS-Cog14, Adjusted mean difference vs. placebo (95% CI)
-1.44 (-2.27 to -0.61), p<0.001
[Death]
lecanemab: 6/898 (0.7%)
placebo: 7/897 (0.8%)[SAE]
lecanemab: 126/898 (14.0%)
placebo: 101/897 (11.3%)
Wang 202031) GV-971 GV-971 600mg (n=84)
GV-971 900mg (n=86)
placebo (n=85) ADAS-Cog12 Change From Baseline: mean (SD)
Placebo (N=83): -1.5 (7.0)
GV-971 600mg (N=76): -1.4 (6.5), p = 0.89
GV-971 900mg (N=83): -2.6 (5.7), p = 0.30
[Death]
600mg: 0/84 (0.0%)
900mg: 0/86 (0.0%)
placebo: 0/85 (0.0%)[SAE]
p=0.58
600mg: 5/84 (6.0%)
900mg: 3/86 (3.5%)
placebo: 6/85 (7.1%)
Xiao 202123) GV-971 GV-971 900 mg (n=407) placebo (n=410) ADAS-Cog12 difference vs placebo(95%CI) from baseline
-2.15 (3.07, -1.23), p<0.0001
[Death]
GV-971: 2/407 (0.5%)
placebo: 0/410 (0.0%)
[SAE]
GV-971: 33/407 (8.1%)
placebo: 29/410 (7.1%)

ADAS-Cog, Alzheimer’s Disease Assessment Scale - Cognitive Subscale; MMSE, Mini-Mental State Examination, K-MMSE, Korean-Mini Mental State Examination; PC Period, placebocontrolled period; SAE, Serious Adverse Event

Korean J Clin Pharm 2023;33:290-304 https://doi.org/10.24304/kjcp.2023.33.4.290
© 2023 Korean J Clin Pharm