Table 2. Primary and Secondary Clinical Outcomes and MRI Volumes at Week 52.
| Characteristic | Placebo | Edonerpic Maleate, 224 mg | P Value | Edonerpic Maleate, 448 mg | P Value | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline, Mean (SD) | Change From Baseline, Mean (SE) | Baseline, Mean (SD) | Change From Baseline, Mean (SE) | Difference vs Placebo, Mean (95% CI) | Baseline, Mean (SD) | Change From Baseline, Mean (SE) | Difference vs Placebo, Mean (95% CI) | |||
| Primary outcomesa | ||||||||||
| ADAS-cog score | 28.1 (10.0) | 7.91 (0.727) | 27.7 (8.6) | 7.45 (0.756) | −0.47 (−2.36 to 1.43) | .63 | 27.8 (10.1) | 7.08 (0.756) | −0.84 (−2.75 to 1.08) | .39 |
| ADCS-CGIC score | NA | 5.22 (0.097) | NA | 5.24 (0.101) | 0.03 (−0.20 to 0.25) | .81 | NA | 5.25 (0.101) | 0.04 (−0.19 to 0.26) | .76 |
| Secondary outcomes | ||||||||||
| ADCS-ADL score | 60.3 (11.11) | −11.29 (0.957) | 60.4 (10.59) | −11.07 (0.992) | 0.23 (−2.29 to 2.74) | .86 | 61.0 (10.92) | −10.01 (0.991) | 1.29 (−1.26 to 3.83) | .32 |
| MMSE score | 18.2 (3.8) | −2.94 (0.416) | 18.2 (3.8) | −2.89 (0.428) | 0.05 (−0.96 to 1.06) | .92 | 18.4 (3.9) | −3.00 (0.426) | −0.06 (−1.08 to 0.96) | .91 |
| Functional Activities Questionnaire scoreb | 17.7 (7.46) | 4.35 (0.433) | 17.8 (7.05) | 5.05 (0.448) | 0.70 (−0.33 to 1.73) | .18 | 16.9 (7.74) | 4.25 (0.448) | −0.10 (−1.14 to 0.93) | .85 |
| Neuropsychiatric Inventory score | 9.3 (10.54) | 4.36 (1.312) | 9.3 (10.31) | 6.77 (1.370) | 2.41 (−1.01 to 5.83) | .17 | 9.5 (10.83) | 3.01 (1.368) | −1.35 (−4.79 to 2.09) | .44 |
| MRI outcomesc,d | ||||||||||
| Brain volume, mL (baseline) | 822.6 (89.8) | NA | 820.7 (102.5) | NA | NA | NA | 840.2 (99.0) | NA | NA | NA |
| Brain volume, pdu | NA | −1.84 (0.29) | NA | −1.48 (0.29) | 0.36 (−0.18 to 0.91) | .19 | NA | −1.48 (0.30) | 0.36 (−0.18 to 0.91) | .19 |
| Lateral ventricle volume, right and left, mL (baseline) | 63.84 (24.3) | NA | 62.18 (23.7) | NA | NA | NA | 65.49 (30.1) | NA | NA | NA |
| Lateral ventricle volume, right and left, pdu | NA | 23.17 (2.00) | NA | 24.66 (2.02) | 1.49 (−2.92 to 5.90) | .51 | NA | 29.16 (2.12) | 5.99 (1.52 to 10.45) | .009 |
| Hippocampal volume, right and left, mL (baseline) | 4.86 (1.02) | NA | 4.88 (0.98) | NA | NA | NA | 4.79 (1.12) | NA | NA | NA |
| Hippocampal volume, right and left, pdu | NA | −4.06 (0.62) | NA | −3.70 (0.63) | 0.36 (−0.93 to 1.65) | .58 | NA | −4.07 (0.66) | −0.01 (−1.31 to 1.29) | .99 |
Abbreviations: ADAS-cog, Alzheimer Disease Assessment Scale–Cognitive Subscale; ADCS-ADL, Alzheimer’s Disease Cooperative Study–Activities of Daily Living; ADCS-CGIC, Alzheimer’s Disease Cooperative Study–Clinical Impression of Change; MMSE, Mini-Mental State Examination; MRI, magnetic resonance imaging; NA, not applicable; pdu, procedure-defined units.
a
Placebo, n = 156; edonerpic maleate, 224 mg, n = 159; and edonerpic maleate, 448 mg, n = 154.
b
For 158 participants at baseline for 224-mg dose on Functional Activities Questionnaire.
c
Placebo, n = 107; edonerpic maleate, 224 mg, n = 89; and edonerpic maleate, 448 mg, n = 85.
d
MRI outcomes at week 52 estimated by mixed models with repeated measures with covariates.