An observational study in Alzheimer's Disease, sponsored by Eisai Inc.. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Eisai Inc. · Observational
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.
As this is a Retrospective Database Study, the Study Start Date for this study references the date at which the first set of data will become available.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 600 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study includes participants with at least one Alzheimer's disease diagnosis in claims data from January 2016 to July 2025 (or the latest available data).
Exclusion Criteria:
Other: No intervention
This is a non-interventional study.
Positive Predictive Value (PPV) of algorithms to identify intracerebral hemorrhage >1 cm in diameter
Time frame: Up to 9.5 years
PPV of algorithms to identify new-onset seizure
Time frame: Up to 9.5 years
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Eisai Inc.