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A Retrospective Database Study for the Development and Validation of Algorithms for Intracerebral Hemorrhage and Seizures in Alzheimer's Disease

StatusActive, Not Recruiting
PhaseNot specified
SponsorEisai Inc.
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Trial status changed: Not Yet Recruiting → Active, Not Recruiting · Study sites: 0 to 1 · Start date changed from estimate of Jul 30, 2026 to May 11, 2026 · 1 more Show 4 more changesShow less
    • Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 30, 2026 to May 11, 2026
    • Eligibility criteria expanded, about 5 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Biogen
92 trials monitored
See 7 trials at risk
Alzheimer's Disease
1,152 trials monitored
See 60 trials at risk
The primary objective of this study is to develop and validate claims-based algorithms to identify intracerebral hemorrhage \>1 cm in diameter, ensuring differentiation from amyloid-related imaging abnormality-microhemorrhage and hemosiderin deposit (ARIA-H; microhemorrhage, superficial siderosis) in participants with Alzheimer's disease (AD) using claims data in the United States (US) with linkage to electronic health records (EHRs), and to estimate the positive predictive values (PPVs) of the algorithms. The secondary objective of the study is to validate claims-based algorithms to identify new-onset seizures in participants with AD using US claims data with linkage to EHRs and to estimate the PPVs of the algorithms.
Trial Details
NCT Number NCT07723950
Lead Sponsor Eisai Inc.
Conditions Alzheimer's Disease
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov