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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Dementia Hemorrhage Intracranial Hemorrhages Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Tauopathies Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Before or on the outcome event date, have at least 1 ICD-10-CM diagnosis code for AD in medical claims in an inpatient setting; or have at least 2 ICD-10-CM diagnosis codes in medical claims in an outpatient setting, at least 7 days and less than 365 days apart
Have at least 365 days of continuous coverage with medical and pharmacy benefits before the outcome event date
Have EHR data available for (1) the outcome event date or (2) during the period of up to 30 days before and up to 90 days after the outcome event date
Have unstructured EHR information (ie, clinical notes) available for any encounter (1) on the outcome event date or (2) during the period of 30 days before to up to 45 days after the outcome event date

Exclusion criteria

New-onset seizure outcome only: Have any ICD-10-CM diagnosis code for seizure or epilepsy before the outcome event date

Treatment and study plan

No intervention

Other

This is a non-interventional study.

Primary outcomes

Positive Predictive Value (PPV) of algorithms to identify intracerebral hemorrhage >1 cm in diameter

Time frame: Up to 9.5 years

Secondary outcomes

PPV of algorithms to identify new-onset seizure

Time frame: Up to 9.5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Eisai Medical Information

CONTACT

[email protected]

+1-888-274-2378

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

Development and Validation of Algorithms for Identifying Intracerebral Hemorrhage and Seizures in Patients With Alzheimer's Disease: A Retrospective Database Study Using United States Healthcare Administrative Claims Data

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 23, 2026
Registry last updated: Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed