Table 1.
Baseline Demographics and Assessment Scores
| Demographics and Clinical Features | All Participants (N = 1649) | Placebo (n = 809) | Tarenflurbil (n = 840) | P Valuea |
|---|---|---|---|---|
| Age, mean (SD) [range], y | 74.6 (8.4) [53−100] | 74.7 (8.4) [53−100] | 74.6 (8.5)[53−100] | .93 |
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| Age range, y, No. (%) | ||||
| <55 | 9 (0.5) | 3 (0.4) | 6 (0.7) | .67 |
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| ≥55−<65 | 218 (13.2) | 110 (13.6) | 108 (12.9) | |
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| ≥65−<75 | 496 (30.1) | 233 (28.8) | 263 (31.3) | |
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| ≥75−<85 | 752 (45.6) | 378 (46.7) | 374 (44.5) | |
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| ≥85 | 174 (10.6) | 85 (10.5) | 89 (10.6) | |
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| Female sex, No. (%) | 840 (50.9) | 425 (52.5) | 415 (49.4) | .20 |
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| Any college, No. (%) | 1028 (62.3) | 499 (61.7) | 529 (63.0) | .59 |
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| White race, No. (%) | 1558 (94.5) | 761 (94.1) | 797 (94.9) | .47 |
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| Time since original diagnosis, mean (SD), mo | 20.4 (19.8) (n = 1238) | 20.5 (21.5) (n = 608) | 20.4 (18.0) (n = 630) | .94 |
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| Apolipoprotein ε4 positive, No. (%) | 750 (58.1) (n = 1292) | 367 (57.9) (n = 634) | 383 (58.2) (n = 658) | .91 |
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| Concomitant medications for AD, No. (%) | ||||
| None | 307 (18.6) | 146 (18.0) | 161 (19.2) | .81b |
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| Acetylcholinesterase inhibitor only | 548 (33.2) | 268 (33.1) | 280 (33.3) | |
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| Memantine only | 103 (6.2) | 48 (5.9) | 55 (6.5) | |
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| Acetylcholinesterase inhibitor and memantine | 690 (41.8) | 347 (42.9) | 343 (40.8) | |
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| Cognitive and functional measure scores, mean (SD)c | ||||
| MMSE | 23.3 (2.0) (n = 1649) | 23.3 (2.0) (n = 809) | 23.3 (2.0) (n = 840) | .63 |
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| ADAS-Cog score, points | ||||
| 80 | 25.9 (8.7) (n = 1643) | 25.7 (8.9) (n = 806) | 26.1 (8.5) (n = 837) | .36 |
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| 70 | 18.0 (7.5) (n = 1644) | 17.8 (7.7) (n = 806) | 18.2 (7.4) (n = 838) | .35 |
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| ADCS-ADL | 63.6 (11.3) (n = 1580) | 63.6 (11.1) (n = 777) | 63.6 (11.5) (n = 803) | .93 |
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| CDR-sb | 4.9 (2.3) (n = 1643) | 5.0 (2.4) (n = 806) | 4.9 (2.3) (n = 837) | .37 |
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| Neuropsychiatric Inventory | 8.4 (9.9) (n = 1606) | 8.6 (10.2) (n = 785) | 8.1 (9.6) (n = 821) | .31 |
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| QOL-AD | 36.9 (6.0) (n = 1370) | 36.7 (6.0) (n = 666) | 37.1 (6.0) (n = 704) | .17 |
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| Caregiver Burden Inventory | 16.1 (13.8) (n= 1421) | 16.3 (14.1) (n = 701) | 15.8 (13.4) (n = 720) | .48 |
Abbreviations: AD, Alzheimer disease; ADAS-Cog, AD Assessment Scale; ADCS-ADL, AD Cooperative Studies-activities of daily living scale; Cognitive Subscale; CDR-sb, Clinica Dementia Rating-sum of boxes; MMSE, Mini-Mental State Examination; QOL, quality of life
a
P value based on Pearson χ2 test.
b
Comparison of the distribution across the 4 categories of concomitant medication use, based on a Pearson χ2 test.
c
See “Methods” section for test total points.