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Table 1 Characteristics of the included studies and outcome events

From: The FDA-approved anti-amyloid-β monoclonal antibodies for the treatment of Alzheimer’s disease: a systematic review and meta-analysis of randomized controlled trials

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

  1. AD Alzheimer’s disease, ARIA amyloid-related imaging abnormalities, MCI Mild Cognitive Impairment, MMSE Mini-Mental State Examination, SD standard deviation
  2. a: Clinical Dementia Rating–Sum of Boxes (CDR-SB); b: Alzheimer’s Disease Assessment Scale- Cognitive Subscale (ADAS-cog); c: Alzheimer’s Disease Composite Score (ADCOMS); d: Alzheimer’s Disease Cooperative Study–Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL); e: Amyloid Burden on PET; f: plasma biomarker Aβ42/40 ratio; g: plasma biomarker p-tau181; h: CSF Aβ1-42; i: CSF T-Tau; j: CSF P-Tau; k: ARIA-H: ARIA with hemosiderin deposits; l: ARIA-E: ARIA with edema or effusions