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

Sponsor
Eisai Inc.
Study ID
NCT07723950
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • No intervention — OTHER
    This is a non-interventional study.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Jul 30, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Alzheimer's Disease Participants in US Claims-EHR Data

Primary Outcome Measure

Positive Predictive Value (PPV) of algorithms to identify intracerebral hemorrhage >1 cm in diameter [ Time Frame: Up to 9.5 years ]

Central Contacts

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