| 1 ADAS‐Cog (change from baseline at 24 weeks) ITT |
2 |
1062 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.35 [‐2.03, ‐0.66] |
| 2 MMSE (change from baseline at 24 weeks) ITT |
2 |
1028 |
Mean Difference (IV, Fixed, 95% CI) |
0.64 [0.26, 1.02] |
| 3 clock drawing (change from baseline at 24 weeks) ITT |
1 |
514 |
Mean Difference (IV, Fixed, 95% CI) |
0.4 [‐0.17, 0.97] |
| 4 TMT‐A (change from baseline at 24 weeks) ITT |
1 |
499 |
Mean Difference (IV, Fixed, 95% CI) |
‐20.0 [‐29.80, ‐10.20] |
| 5 Mental Function Impairment MENFIS (change from baseline at 24 weeks) ITT |
1 |
537 |
Mean Difference (IV, Fixed, 95% CI) |
‐1.30 [‐2.32, ‐0.28] |
| 6 ADCS‐ADL (change from baseline at 24 weeks) ITT |
1 |
528 |
Mean Difference (IV, Fixed, 95% CI) |
2.20 [0.62, 3.78] |
| 7 Disability Assessment for Dementia (DAD) (change from baseline at 24 weeks) ITT |
1 |
536 |
Mean Difference (IV, Fixed, 95% CI) |
2.30 [0.34, 4.26] |
| 8 BEHAVE‐AD (change from baseline at 24 weeks) ITT |
1 |
537 |
Mean Difference (IV, Fixed, 95% CI) |
‐0.20 [‐0.92, 0.52] |
| 9 NPI‐12 (change from baseline at 24 weeks) ITT |
1 |
529 |
Mean Difference (IV, Fixed, 95% CI) |
0.0 [‐2.16, 2.16] |
| 10 Clinical Global Impression (no change or worse at 24 weeks) |
2 |
1063 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.77 [0.58, 1.02] |
| 11 withdrawals before end of treatment at 24 weeks |
2 |
1170 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.67 [1.23, 2.26] |
| 12 at least one adverse event by 24 weeks |
2 |
1460 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.63 [1.29, 2.06] |
| 13 withdrawals due to an adverse event before end of treatment at 24 weeks |
2 |
1170 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.84 [1.20, 2.82] |
| 14 at least one adverse event of application site erythema by 24 weeks |
1 |
573 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.73 [1.87, 3.98] |
| 15 at least one adverse event of application site pruritis by 24 weeks |
1 |
573 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.97 [1.36, 2.86] |
| 16 at least one adverse event of application site edema by 24 weeks |
1 |
573 |
Odds Ratio (M‐H, Fixed, 95% CI) |
4.83 [2.09, 11.15] |
| 17 at least one adverse event application site exfoliation by 24 weeks |
1 |
573 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.81 [0.88, 8.93] |
| 18 at least one adverse event of dermatitis contact by 24 weeks |
1 |
573 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.91 [1.24, 2.94] |
| 19 at least one adverse event of nasopharyngitis by 24 weeks |
1 |
573 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.03 [0.62, 1.73] |
| 20 at least one adverse event of nausea by 24 weeks |
2 |
1166 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.80 [1.07, 3.02] |
| 21 at least one adverse event of vomiting by 24 weeks |
2 |
1166 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.06 [1.20, 3.53] |
| 22 at least one adverse event of diarrhoea by 24 weeks |
1 |
593 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.93 [0.87, 4.24] |
| 23 at least one adverse event of weight decrease by 24 weeks |
1 |
593 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.11 [0.63, 7.07] |
| 24 at least one adverse event of dizziness by 24 weeks |
1 |
593 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.04 [0.36, 3.00] |
| 25 at least one adverse event of decreased appetite by 24 weeks |
1 |
593 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.69 [0.11, 4.16] |
| 26 at least one adverse event of headache by 24 weeks |
1 |
593 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.11 [0.71, 6.26] |
| 27 at least one adverse event of asthenia by 24 weeks |
1 |
593 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.74 [0.41, 7.36] |
| 28 deaths before end of treatment at 24 weeks |
2 |
1170 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.02 [0.28, 3.81] |
| 29 NPI‐D carer distress scale (change from baseline at 24 weeks) ITT |
1 |
529 |
Mean Difference (IV, Fixed, 95% CI) |
0.10 [‐0.91, 1.11] |
