NCT07723950Active, not recruiting
A Retrospective Database Study for the Development and Validation of Algorithms for Intracerebral Hemorrhage and Seizures in Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- 11 May 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Eisai Inc.
- Diseases
- Alzheimer disease
- NCT number
- NCT07723950
What you commit to
- Study type: Observational
- Planned participants: 600
- From 11 May 2026 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- New-onset seizure outcome only: Have any ICD-10-CM diagnosis code for seizure or epilepsy before the outcome event date
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Eisai Site #1 Coordinator of this site? Confirm its status | Nutley | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.