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Every row of the evidence table
One row per finding: what was tested, which way the result went, and how the study was built. The answer by area, and where the studies disagree, are on the main page.
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Showing 4 of 382 rows. One row per study per exposure: a study that tested two different things appears twice, once for each.
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| Exposure | Question | Direction | Outcome measured | Design | People | Effect size, as the source reported it | Source |
|---|---|---|---|---|---|---|---|
| Anti-amyloid antibody Medicines | Treatment |
Benefit
whyAn initial negative opinion was reversed on re-examination, with use restricted to APOE4 heterozygotes and non-carriers. The EPAR describes ARIA as affecting more than 1 in 10 people without giving a percentage. |
iADRS at 18 months, in the APOE4-restricted group | regulatory decision | 1,736 | "after 18 months of treatment, the iADRs score worsened by 11 points in patients who received Kisunla and 13 points in those given placebo" |
European Medicines Agency
2025 ⚠ Regulatory decision — not a study no DOI or PMID exists |
| Anti-amyloid antibody Medicines | Treatment | Benefit | iADRS and CDR-SB at week 76 | regulatory decision | 1,736 | Week 76 differences from placebo: iADRS 2.92 (p<0.0001); ADAS-Cog13 -1.33 (p=0.0006); ADCS-iADL 1.70 (p=0.0001); CDR-SB -0.70 (p<0.0001) |
U.S. Food and Drug Administration
2024 ⚠ Regulatory decision — not a study no DOI or PMID exists |
| Anti-amyloid antibody Medicines | Treatment | Benefit | CDR-SB (clinical progression) at 18 months | regulatory decision | 1,795 | "Leqembi demonstrated a statistically significant and clinically meaningful reduction of decline from baseline to 18 months on the primary endpoint, the Clinical Dementia Rating Scale Sum of Boxes score, compared to placebo" — the notice gives no numeric CDR-SB difference |
U.S. Food and Drug Administration
2023 ⚠ Regulatory decision — not a study no DOI or PMID exists |
| Anti-amyloid antibody Medicines | Treatment |
Benefit
whyBenefit is on the surrogate marker only: the approval rested on amyloid reduction, not on confirmed clinical benefit, and the confirmatory trial was later terminated. |
Amyloid PET (surrogate marker) | regulatory decision | not stated | not established — the library recorded "amyloid-pet reduction of 71% (emerge) and 59% (engage), both p<0.0001". investors.biogen.com timed out on repeated attempts… |
U.S. Food and Drug Administration (announced via Biogen press release)
2021 ⚠ Regulatory decision — not a study no DOI or PMID exists |