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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 7 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 |
Mixed
whyCHMP refused the drug, then on re-examination recommended it only for people with one or no APOE4 copy, where the ARIA rates are lower. Benefit on cognition and harm from ARIA in the same document, with the restriction as the regulator's way of balancing them. |
CDR-SB at 18 months and ARIA rates, in the APOE4-restricted group | regulatory decision | 1,521 | "After 18 months of treatment, patients treated with Leqembi had a smaller increase in CDR-SB score than those who received placebo (1.22 versus 1.75)"; "8.9% of those with only one or no copy of ApoE4 experienced ARIA-E, compared with 12.6% of all patients ... 12.9% of patients in the restricted population experienced ARIA-H compared with 16.9% of the broader population"; placebo figures 1.3% and 6.8% |
European Medicines Agency
2024 ⚠ Regulatory decision — not a study no DOI or PMID exists |
| Anti-amyloid antibody Medicines | Treatment |
Mixed
whyApproved on amyloid reduction (surrogate) while reporting higher ARIA rates than placebo; the notice reports no cognitive outcome. |
Amyloid PET (surrogate marker); ARIA rates | regulatory decision | not stated | not established — the library recorded "aria-e in 10% of lecanemab patients vs 1% placebo; aria-h in 6% vs 5%". investors.biogen.com timed out on repeated attempts… |
U.S. Food and Drug Administration (announced via Biogen press release)
2023 ⚠ 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 |
| Other investigational drug Medicines | Treatment |
No direction reported
whyA regulatory enforcement action, not a study. The SEC's order finds the reported Phase 2 biomarker data were manipulated by an unblinded consultant and its complaint alleges the full patient data "showed no measurable cognitive improvement in the patients' episodic memory"; it estimates no effect. |
Securities-fraud settlement over reported Phase 2 simufilam results | regulatory decision | not stated | not established — sec press release 2024-151, fetched from sec.gov via a reader proxy. it states civil penalties of $40 million (cassava), $175,000 (barbier) and… |
SEC Press Release / Administrative Order (Securities Act of 1933 Release No. 11311)
2024 ⚠ Regulatory decision — not a study no DOI or PMID exists |