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Every row

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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Research and outcomes, 4 rows. Every row links to its source.
Exposure Question Direction Outcome measured Design People Effect size, as the source reported it Source
Anti-amyloid antibody Medicines Treatment Benefit
why

An 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
why

Benefit 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

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