Biomarker Analysis Plan.pdf

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Preview of Biomarker Analysis Plan
🔗 Source: jpreventionalzheimer.com
📊 Size: 959 KB
📄 Pages: 12 pages
⬇️ Downloads: 169

Summary

The Statistical Analysis Plan for exploratory biomarkers in phase III studies 221AD301 and 221AD302 outlines pre-planned analysis for biomarkers collected to evaluate aducanumab's efficacy and safety in early Alzheimer's disease subjects. The plan focuses on the placebo-controlled period to assess treatment effect on biomarkers, with long-term extension data summarized. Exploratory objectives include assessing aducanumab's effect on morphometric measures, functional connectivity, cerebral blood flow, disease-related biomarkers in CSF and blood, and tau pathology. Endpoints include changes from baseline in whole brain volume, functional connectivity, cerebral blood flow, CSF and blood biomarkers, and tau PET signal.

Description

The Statistical Analysis Plan for exploratory biomarkers in phase III studies 221AD301 and 221AD302 outlines pre-planned analysis for biomarkers collected to...

Technical Information

  • File Format: PDF
  • File Size: 959 KB
  • Pages: 12
  • Language: EN
  • Total Downloads: 169
  • Last Updated: 4 days ago

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This PDF document about Biomarker Analysis Plan provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into Biomarker Analysis Plan.

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