Cerebrospinal Fluid Mitochondrial Biomarkers in Ischemic Stroke and Alzheimer Disease (NCT07600996) | Clinical Trial Compass
RecruitingNot Applicable
Cerebrospinal Fluid Mitochondrial Biomarkers in Ischemic Stroke and Alzheimer Disease
China40 participantsStarted 2026-03-01
Plain-language summary
This prospective observational study aims to investigate cerebrospinal fluid mitochondrial biomarkers in patients with ischemic stroke and Alzheimer disease controls who undergo diagnostic lumbar puncture for clinical indications at Xuanwu Hospital, Capital Medical University.
Residual cerebrospinal fluid samples will be analyzed by flow cytometry to quantify mitochondrial content, mitochondrial membrane potential, and cellular or vesicular source-related markers. The flow cytometry panel will include MitoTracker, JC-1, and membrane-associated markers including CD45, CD41, CD24, vWF, and EAAT1.
In patients with ischemic stroke, the study will further examine whether cerebrospinal fluid mitochondrial measurements are associated with neurological severity and functional outcomes, including admission and discharge NIHSS scores and the 90-day modified Rankin Scale score. Alzheimer disease patients undergoing diagnostic lumbar puncture will serve as disease controls for biomarker comparison.
Who can participate
Age range
18 Years
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:
* Age 18 years or older. Patients treated at Xuanwu Hospital, Capital Medical University between March 2026 and May 2026.
Diagnosis of ischemic stroke or Alzheimer disease according to standard clinical diagnostic criteria.
Diagnostic lumbar puncture performed for clinical indications as part of routine medical care.
Availability of residual cerebrospinal fluid after completion of clinically required testing.
Ability to provide written informed consent, or availability of a legally authorized representative to provide consent when appropriate.
For ischemic stroke patients, availability of baseline neurological assessment and planned follow-up for 90-day modified Rankin Scale assessment.
Exclusion Criteria:
* Lumbar puncture performed solely for research purposes rather than clinical indication.
Insufficient residual cerebrospinal fluid volume for research flow cytometry analysis.
Grossly bloody or severely contaminated cerebrospinal fluid sample that precludes reliable flow cytometry analysis.
Known central nervous system infection, malignant meningitis, or other inflammatory or neoplastic condition that, in the investigator's judgment, may substantially confound cerebrospinal fluid mitochondrial measurements.
Inability to obtain informed consent from the participant or legally authorized representative.
Missing key clinical outcome data, including admission NIHSS, discharge NIHSS, or planned 90-day mRS follow-up for ischemic stroke participan…
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.
1This study involves collecting cerebrospinal fluid, which typically requires a lumbar puncture — can you walk me through what that procedure involves and what the risks are for someone in my situation?
2Since this is a biomarker research study and not a treatment trial, does participating offer any direct medical benefit to me, or is it mainly contributing to future research on stroke and Alzheimer's disease?
3The study is measuring something called MitoTracker-positive events in spinal fluid and linking them to how well stroke patients recover at 90 days — what does that tell us about whether this research is relevant to my specific diagnosis and recovery goals?
4Given that this study involves both ischemic stroke and Alzheimer's disease patients, am I the type of patient they're looking for, and would participating in any way interfere with or delay my standard treatment or rehabilitation?
5Are there other studies or standard-of-care options I should be considering alongside or instead of this one, especially since this trial isn't testing a new treatment but rather studying biological markers?
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
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and 90-Day Modified Rankin Scale Score in Patients With Ischemic Stroke