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)
|
- 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
- *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)
- †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)