pISSN 1226-6051
eISSN 2508-786X

Table. 1.

Table. 1.

Characteristics of the included studies for the review

Study Target type Therapy type Study drug Study design Country Study population Sample size Treatment duration
Cohen 202116) (EMERGE) Amyloid-Related Immunotherapy Aducanumab phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study 13 countries including US Age 50-85, AD patients
CDR-GS 0.5, MMSE 24~30
1,638 78 weeks
Hannestad 202129) Inflammation, other, unknown Other GRF6019 randomized, double-blind, placebo-controlled phase II safety study United States Age 60–95
AD based on the NIAAA, MMSE = 0–10
26 9 weeks
Koh 202130) other Immunotherapy (active) GV1001 phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial Korea Age 55–85
probable AD, K-MMSE ≤ 19, GDS 5–6, donepezil 10 mg for > 3M
96 24 weeks
Mintun 202118) Amyloid-Related Immunotherapy (passive) Donanemab multicenter, randomized, double-blind, placebo-controlled phase 2 trial United States, Canada Age 60-85
prodromal AD, mild AD, MMSE 20-28
272 76 weeks
Ostrowitzki 202219) [CREAD] Amyloid-Related Immunotherapy (passive) Crenezumab phase 3 multicenter randomized double-blind placebo-controlled parallel-group trial 194 sites in 30 countries Age 55~85
early AD
813 105 weeks
Ostrowitzki 202219) [CREAD2] Amyloid-Related Immunotherapy (passive) Crenezumab phase 3 multicenter randomized double-blind placebo-controlled parallel-group trial 209 sites in 27 countries Age 55~85
early AD
806 105 weeks
Prins 202124) Inflammation Small Molecule Neflamapimod multi-center Ph 2, randomized, parallel-group, double-blind placebo controlled trial US, UK, Netherlands, Czech Republic, Denmark Age 55~85
CDR GS 0.5 or 1.0
MMSE 20~28
161 24 weeks
Budd 202217) [ENGAGE] Amyloid-Related Immunotherapy Aducanumab randomized, double-blind, placebo- controlled, Phase 3 studies 20 countries including US Age 50 - 85 stage 3 and 4 (FDA 2018)
MMSE 24-30
CDR-GS 0.5
1,653 78 weeks
Sperling 202115) Amyloid-Related (BACE inhibitor) Small Molecule Atabecestat randomized, double-blind, placebo-controlled, phase 2b/3 study conducted at 143 centers across 14 countries Age 65~85
CDR global score of 0 and generally healthy participants
557 up to 54 months
Swanson 202120) Amyloid-Related Immunotherapy (passive) Lecanemab multicenter, double-blind, placebo-controlled Bayesian design clinical trial MCI due to AD or mild AD dementia.
MMSE 22~28 in EU, except Italy
856 18 months
Teng 202222) Tau Immunotherapy (passive) Semorinemab phase 2 randomized, double-blind, placebo-controlled, parallel-group clinical trial North America, Europe, Australia Age 50-80
prodromal to mild AD, MMSE 20-30
457 18 months
van Dyck 202321) Amyloid-Related Immunotherapy (passive) Lecanemab multicenter, double-blind, placebo-controlled, parallel-group, phase 3 trial North America, Europe, Asia Age 50 - 90
MCI due to AD or mild AD-related dementia (NIAAA)
1,795 18 months
Wang 202031) Aβ aggregation inhibitor Small Molecule GV-971 double-blind, placebo-controlled, randomized phase 2 study China Probable AD
Age 50~85
MMSE 10~24
255 24 weeks
Xiao 202123) Inflammation Small Molecule GV-971 phase 3, double-blind, placebo-controlled trial China Age 50-85
mild-to-moderate AD
MMSE 11-22
818 36 weeks
Nirogi 202226) Other Neurotransmitters Small Molecule Masupirdine phase 2, double‐blind, multicenter, randomized, parallel group, placebo-controlled study Age 50-85
MMSE 12-20
564 26 weeks

AD, Alzheimer’s Disease; CDR-GS, Clinical Dementia Rating – Global Score; MMSE, Mini-Mental State Examination; NIAAA, National Institute on Aging-Alzheimer's Association; KMMSE, Korean-Mini Mental State Examination; GDS, Global Deterioration Scale; MCI, Mild Cognitive Impairment

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