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. 2020 Dec 15;2020(12):CD011679. doi: 10.1002/14651858.CD011679.pub2

Comparison 3. Souvenaid versus placebo in mild to moderate dementia due to Alzheimer's disease.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
3.1 Cognition: ADAS‐Cog 1 428 Mean Difference (IV, Fixed, 95% CI) 1.02 [‐1.11, 3.15]
3.2 Cognition: Global cognitive function composite score z‐score (4 components) 1 364 Mean Difference (IV, Fixed, 95% CI) 0.08 [‐0.07, 0.23]
3.3 Functional outcomes: ADCS‐ADL 1 451 Mean Difference (IV, Fixed, 95% CI) 0.51 [‐2.40, 3.42]
3.4 Combined cognitive‐functional outcome: CDR‐SoB 1 450 Mean Difference (IV, Fixed, 95% CI) ‐0.12 [‐0.74, 0.50]
3.5 General safety (follow up 24 weeks, all subjects treated population) 1   Risk Ratio (M‐H, Fixed, 95% CI) Subtotals only
3.5.1 Any adverse event 1 524 Risk Ratio (M‐H, Fixed, 95% CI) 0.90 [0.78, 1.03]
3.5.2 Any serious adverse event 1 524 Risk Ratio (M‐H, Fixed, 95% CI) 0.78 [0.49, 1.26]
3.5.3 Dropout overall 1 527 Risk Ratio (M‐H, Fixed, 95% CI) 0.94 [0.62, 1.42]
3.5.4 Dropout due to (serious) adverse events 1 527 Risk Ratio (M‐H, Fixed, 95% CI) 0.49 [0.09, 2.68]