A Retrospective Database Study for the Development and Validation of Algorithms for Intracerebral… (NCT07723950) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Retrospective Database Study for the Development and Validation of Algorithms for Intracerebral Hemorrhage and Seizures in Alzheimer's Disease
600 participantsStarted 2026-07-30
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Positive Predictive Value (PPV) of algorithms to identify intracerebral hemorrhage >1 cm in diameter