Study | NCT | Countries | Centers | Publications | Number of participants (treatment vs. placebo) | Drug and dose | Male (%) (treatment vs. placebo) | Mean age ± SD (year) (treatment vs. placebo) | Study period | AD stage (MMSE score or global CDR score for inclusion) | MMSE, mean ± SD (treatment vs. Placebo) | CDR-SB score, mean ± SD (treatment vs. Placebo) | Outcome Events |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
van Dyck CH 2023 | NCT03887455 | USA | Multicenter | The New England Journal of Medicine | 898 897 | Lecanemab, 10 mg/kg | 48.4 47.0 | 71.4 ± 7.9 71.0 ± 7.8 | 18 months | MCI due to AD or mild AD (Global CDR 0.5 or 1) | 25.5 ± 2.2 25.6 ± 2.2 | 3.17 ± 1.34 3.22 ± 1.34 | a, b, c, d, e, f, g, h, i, j, k, l |
Swanson CJ 2022 | NCT01767311 | USA | Multicenter | Alzheimer's Research & Therapy | 152 238 | Lecanemab, 10 mg/kg | 57.9 42.4 | 72.6 ± 8.8 71.1 ± 8.9 | 18 months | MCI due to AD or mild AD dementia (MMSE 22–28) | 25.6 (2.4) 26.0 (2.3) | 3.0 ± 1.4 2.9 ± 1.5 | a, b, c, e, k, l |
McDade E 2022 | NCT01767311 | USA | Multicenter | Alzheimer’s Research & Therapy | 152 238 | Lecanemab,10 mg/kg | 57.9 42.4 | 72.6 ± 8.8 71.1 ± 8.9 | 18 months | MCI due to AD or mild AD (global CDR 0.5 or 1) | 25.6 (2.4) 26.0 (2.3) | 3.0 ± 1.4 2.9 ± 1.5 | f, g |
Budd Haeberlein, S EMERGE 2022 | NCT02484547 | USA | Multicenter | J Prev Alz Dis | 547 548 | Aducanumab, High dose (6 mg/kg (ApoEε4 +) or 10 mg/kg) | 48 47 | 70.6 ± 7.5 70.8 ± 7.4 | 78week | MCI due to AD or mild AD dementia (MMSE 24–30 or global CDR 0.5) | 26.3 ± 1.7 26.4 ± 1.8 | 2.51 ± 1.05 2.47 ± 1.00 | a, b, d, e, g, h, i, j, k, l |
Budd Haeberlein, S ENGAGE 2022 | NCT02477800 | USA | Multicenter | J Prev Alz Dis | 555 545 | Aducanumab, high dose (6 mg/kg (ApoEε4 +) or 10 mg/kg) | 47 47 | 70.0 ± 7.7 69.8 ± 7.7 | 78week | MCI due to AD or mild AD dementia (MMSE 24 -30 or global CDR 0.5) | 26.4 ± 1.8 26.4 ± 1.7 | 2.40 ± 1.01 2.40 ± 1.01 | a, b, d, e, g, h, i, j, k, l |
Sevigny, J 2016 | NCT01677572 | USA | Multicenter | Nature | 32 40 | Aducanumab,10 mg/kg | 53 42 | 73.7 ± 8.3 72.8 ± 7.2 | 54week | prodromal to mild AD (MMSE 20–26 or global CDR 0.5 or 1) | 24.8 ± 3.1 24.7 ± 3.6 | 3.14 ± 1.71 2.66 ± 1.50 | a, e, k, l |
Ferrero J 2016 | NCT01397539 | USA | Multicenter | Alzheimer’s & Dementia: TRCI | 6 13 | Aducanumab, 10 mg/kg | 17 36 | 72.7 ± 4.5 66.9 ± 8.7 | 24week | mild-to-moderate AD (MMSE 14–26) | 18.3 (4.9) 22.1 (2.4) | B |