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

NCT07723950 | Not Yet Recruiting

• 1 other identifier: BAN2401-A001-502
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Intracerebral Hemorrhage; Seizures; US Healthcare Claims Data

Outcome Measures

Primary Outcomes (1)

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

  Up to 9.5 years

Secondary Outcomes (1)

• PPV of algorithms to identify new-onset seizure

  Up to 9.5 years

Study Arms (1)

Alzheimer's Disease Participants in US Claims-EHR Data

Other: No intervention

Interventions

No intervention OTHER

This is a non-interventional study.

Alzheimer's Disease Participants in US Claims-EHR Data

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eisai Inc.: lead

MeSH Terms

Conditions

Alzheimer Disease; Cerebral Hemorrhage; Seizures

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Eisai Medical Information

CONTACT

+1-888-274-2378; esi_medinfo@eisai.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share