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Table 1 Baseline characteristics. Baseline characteristics were reasonably well balanced across doses for each category, with the exception of ApoE4 status. The imbalance in ApoE4 status on the 10 mg/kg monthly and 10 mg/kg biweekly doses is directly related to the change in study design brought about by Health Authority interactions

From: A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody

Category   Lecanemab  
Placebo 2.5 mg/kg biweekly 5 mg/kg monthly 5 mg/kg biweekly 10 mg/kg Monthly 10 mg/kg biweekly Total Lecanemab
(N = 238) (N = 52) (N = 48) (N = 89) (N = 246) (N = 152) (N = 587)
Age, median (range), years 72 (50–89) 71 (50–86) 71 (55–84) 72 (52–87) 71 (53–90) 73 (51–88) 72 (50–90)
Female, n (%) 137 (58) 26 (50) 24 (50) 48 (54) 110 (45) 64 (42) 272 (46)
CDR Global = 0.5 200 (84) 44 (85) 40 (83) 77 (87) 210 (85) 133 (88) 504 (86)
Mild cognitive impairment 154 (65) 34 (65) 33 (69) 52 (58) 166 (68) 90 (59) 375 (64)
ApoE4 positive 169 (71) 38 (73) 37 (77) 81 (91) 218 (89) 46 (30) 420 (72)
Ongoing treatment with AChEIs and/or memantine 128 (54) 28 (54) 25 (52) 56 (63) 131 (53) 79 (52) 319 (54)
ADCOMS, mean (SD) 0.37 (0.17) 0.39 (0.20) 0.40 (0.17) 0.39 (0.16) 0.37 (0.15) 0.37 (0.15) 0.38 (0.16)
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) 22.2 (7.4)
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) 3.0 (1.4)
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) 25.6 (2.4)
PET SUVr, mean (SD) 1.40 (0.16) 1.41 (0.11) 1.42 (0.17) 1.40 (0.12) 1.42 (0.18) 1.37 (0.16) 1.41 (0.16)
  1. CDR, Clinical Dementia Rating; ApoE4, apolipoprotein E4; AChEIs, acetylcholinesterase inhibitors; ADCOMS, the Alzheimer’s Disease Composite Score; ADAS-Cog14, Alzheimer’s disease Assessment Scale-Cognitive Subscale; CDR-SB, Clinical Dementia Rating-Sum-of-Boxes; MMSE, Mini Mental State Examination; PET SUVr, positron emission tomography standard uptake value ratio
  2. *In the ADAS-Cog14 assessment, there were 237 subjects in the placebo group and 586 in the total lecanemab group (2.5 mg/kg biweekly = 52; 5 mg/kg monthly = 47; 5 mg/kg biweekly = 89; 10 mg/kg monthly = 246; 10 mg/g biweekly = 152)
  3. In the PET sub-study, there were 99 subjects in the placebo group and 216 in the total lecanemab group (2.5 mg/kg biweekly = 28; 5 mg/kg monthly = 28; 5 mg/kg biweekly = 27; 10 mg/kg monthly = 89; 10 mg/g biweekly = 44)