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Table 1 Baseline characteristics

From: Lecanemab in patients with early Alzheimer’s disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study

Category

CORE

OLE

 

Lecanemab

Lecanemab

Placebo (N=238)

2.5 mg/kg biweekly (N=52)

5 mg/kg monthly (N=48)

5 mg/kg biweekly (N=89)

10 mg/kg monthly (N=246)

10 mg/kg biweekly (N=152)

Prior core placebo

(N=42)

Prior core 10 mg/kg biweekly (N=37)

10 mg/kg biweekly (N=180)

Age (year)a

Mean (SD)

71.1 (8.9)

70.5 (8.3)

70.4 (7.5)

70.6 (7.4)

71.3 (7.5)

72.6 (8.8)

71.8 (8.2)

76.9 (7.0)

74.0 (7.7)

Sex, n (%)

Female

137 (57.6)

26 (50.0)

24 (50.0)

48 (53.9)

110 (44.7)

64 (42.1)

21 (50.0)

18 (48.6)

87 (48.3)

Region, n (%)

North America

195 (81.9)

47 (90.4)

41 (85.4)

70 (78.7)

215 (87.4)

135 (88.8)

30 (71.4)

32 (86.5)

139 (77.2)

Western Europe

28 (11.8)

4 (7.7)

6 (12.5)

7 (7.9)

15 (6.1)

10 (6.6)

3 (7.1)

2 (5.4)

12 (6.7)

Asia Pacific

15 (6.3)

1 (1.9)

1 (2.1)

12 (13.5)

16 (6.5)

7 (4.6)

9 (21.4)

3 (8.1)

29 (16.1)

Amyloid PET SUVr*

Mean (SD)

1.4 (0.2)

1.4 (0.1)

1.4 (0.2)

1.4 (0.1)

1.4 (0.2)

1.4 (0.2)

1.4 (0.2)

1.1 (0.1)

1.2 (0.2)

Amyloid Centiloids*

Mean (SD)

84.8 (37.4)

87.7 (26.4)

89.4 (39.7)

84.9 (28.0)

90.3 (41.5)

78.0 (38.0)

77.2 (42.0)

8.6 (30.9)

44.5 (43.9)

CDR-Global, n (%)

0.5

200 (84.0)

44 (84.6)

40 (83.3)

77 (86.5)

210 (85.4)

133 (87.5)

19 (45.2)

19 (51.4)

80 (44.4)

1

38 (16.0)

8 (15.4)

8 (16.7)

12 (13.5)

13 (14.6)

19 (12.5)

18 (42.9)

11 (29.7)

68 (37.8)

CDR-SB

Mean (SD)

2.9 (1.5)

3.0 (1.6)

2.9 (1.4)

3.0 (1.3)

2.9 (1.3)

3.0 (1.4)

4.7 (3.2)

5.0 (3.7)

5.3 (3.5)

ApoE4 status, n (%)

Carrier

169 (71.0)

38 (73.1)

37 (77.1)

81 (91.0)

218 (88.6)

46 (30.3)

30 (71.4)

3 (8.1)

125 (69.4)

Heterozygous

129 (54.2)

33 (63.5)

26 (54.2)

67 (75.3)

160 (65.0)

38 (25.0)

4 (9.5)

0

97 (53.9)

Homozygous

40 (16.8)

5 (9.6)

11 (22.9)

14 (15.7)

58 (23.6)

8 (5.3)

26 (61.9)

3 (8.1)

28 (15.6)

Noncarrier

69 (29.0)

14 (26.9)

11 (22.9)

8 (9.0)

28 (11.4)

106 (69.7)

12 (28.6)

34 (91.9)

55 (30.6)

Disease stage, n (%)

MCI due to AD

154 (64.7)

34 (65.4)

33 (68.8)

52 (58.4)

166 (67.5)

90 (59.2)

27 (64.3)

22 (59.5)

110 (61.1)

Mild AD

84 (35.3)

18 (34.6)

15 (31.3)

37 (41.6)

80 (32.5)

62 (40.8)

15 (35.7)

15 (40.5)

70 (38.9)

ADCOMS

Mean (SD)

0.4 (0.2)

0.4 (0.2)

0.4 (0.2)

0.4 (0.2)

0.4 (0.2)

0.4 (0.2)

0.6 (0.3)

0.6 (0.4)

0.7 (0.4)

ADAS-cog14

Mean (SD)

22.6 (7.7)

22.7 (8.1)

22.9 (7.7)

22.8 (6.7)

21.9 (7.3)

22.1 (7.7)

33.4 (13.5)

32.5 (13.8)

35.1 (14.0)

MMSE

Mean (SD)

26.0 (2.3)

25.7 (2.5)

25.3 (2.6)

25.6 (2.3)

25.7 (2.4)

25.6 (2.4)

21.5 (6.3)

21.2 (6.0)

20.7 (6.6)

  1. AChEIs acetylcholinesterase inhibitor, AD Alzheimer’s disease, ApoE4 apolipoprotein E4, CDR Clinical Dementia Rating, MCI mild cognitive impairment, OLE open-label extension, SD standard deviation, ADAS-Cog14 Alzheimer Disease Assessment Scale - Cognitive Subscale with 14 tasks, ADCOMS Alzheimer’s Disease Composite Score, CDR-SB Clinical Dementia Rating Sum-of-Boxes, Max maximum, Min minimum, MMSE Mini-Mental State Examination. a: Age was calculated at date of informed consent. Percentages are based on total number of subjects with non-missing values in relevant treatment group; for OLE, age is calculated at Date of Informed Consent for OLE Phase. MCI due to AD: (a) meet NIA-AA core clinical criteria for MCI due to AD; (b) CDR score of 0.5 and Memory box score of 0.5 or greater at screening and baseline; (c) Report of a history of subjective memory decline w/ gradual onset and slow progression over last year before screen (verified by informant). Mild AD: (a) meet NIA-AA core clinical criteria for probable AD dementia; (b) CDR score of 0.5 to 1.0 and Memory box score of 0.5 or greater at screening and baseline
  2. * The number of subjects in amyloid substudy was 315 in core and 91 in OLE (core: placebo=99; 2.5 mg/kg biweekly=28; 5 mg/kg monthly=28; 5 mg/kg biweekly=27; 10 mg/kg monthly=89; 10 mg/kg biweekly=44; OLE: prior core placebo=27; prior core placebo=22, prior core 10BW==21, total=91. 42 out of 45 subjects in prior core placebo group and 37 out of 38 subjects in prior core 10 mg/kg biweekly group are included in OLE Full Analysis Set and summarized here