A Prospective Observational Study of Cerebrospinal Fluid Mitochondrial Biomarkers Measured by Flow Cytometry in Patients With Ischemic Stroke and Alzheimer Disease Controls

NCT07600996 | Recruiting DMC

• 1 other identifier: CSF-MITO
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; Alzheimer Disease (AD)

Keywords

Cerebrospinal fluid; Mitochondria; MitoTracker; NIHSS; Stroke outcome

Outcome Measures

Primary Outcomes (1)

• Association Between Cerebrospinal Fluid Mitochondrial Content and 90-Day Modified Rankin Scale Score in Ischemic Stroke

  The primary outcome is the association between cerebrospinal fluid mitochondrial content, measured by flow cytometry using MitoTracker-positive events or MitoTracker fluorescence intensity, and functional outcome at 90 days assessed by the modified Rankin Scale. The modified Rankin Scale ranges from 0 to 6, with higher scores indicating greater disability or death.

  From baseline cerebrospinal fluid collection to 90 days after stroke onset or hospital admission

Secondary Outcomes (4)

• Association Between Cerebrospinal Fluid Mitochondrial Content and Admission NIHSS Score

  At hospital admission or baseline clinical assessment

• Association Between Cerebrospinal Fluid Mitochondrial Content and Discharge NIHSS Score

  At hospital discharge, up to 7 days after admission

• Cerebrospinal Fluid Mitochondrial Membrane Potential Measured by JC-1

  At baseline cerebrospinal fluid collection

• Comparison of Cerebrospinal Fluid Mitochondrial Biomarkers Between Ischemic Stroke and Alzheimer Disease Controls

  At baseline cerebrospinal fluid collection

Study Arms (2)

Ischemic Stroke Cohort

Patients diagnosed with ischemic stroke who undergo diagnostic lumbar puncture for clinical indications at Xuanwu Hospital, Capital Medical University. Residual cerebrospinal fluid will be analyzed by flow cytometry to assess mitochondrial content, mitochondrial membrane potential, and membrane-associated markers. Clinical outcomes will include admission NIHSS, discharge NIHSS, and 90-day modified Rankin Scale score.

Diagnostic Test: Cerebrospinal Fluid Flow Cytometry

Alzheimer Disease Control Cohort

Patients diagnosed with Alzheimer disease who undergo diagnostic lumbar puncture for clinical indications at Xuanwu Hospital, Capital Medical University. Residual cerebrospinal fluid will be analyzed by the same flow cytometry panel and used as a disease control group for comparison of cerebrospinal fluid mitochondrial and membrane-marker profiles.

Diagnostic Test: Cerebrospinal Fluid Flow Cytometry

Interventions

Cerebrospinal Fluid Flow Cytometry DIAGNOSTIC_TEST

Residual cerebrospinal fluid obtained during clinically indicated diagnostic lumbar puncture will be analyzed by flow cytometry. The assay will measure mitochondrial signal using MitoTracker, mitochondrial membrane potential using JC-1, and membrane-associated markers including CD45, CD41, CD24, vWF, and EAAT1. The study does not assign participants to any treatment or diagnostic procedure beyond routine clinical care.

Alzheimer Disease Control Cohort; Ischemic Stroke Cohort

Eligibility Criteria

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

Study Population

The study population will include adult patients treated at Xuanwu Hospital, Capital Medical University between March 2026 and May 2026 who are diagnosed with ischemic stroke or Alzheimer disease and require diagnostic lumbar puncture for clinical indications. Only patients with available residual cerebrospinal fluid after completion of routine clinical testing will be included.

You may qualify if:

• 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.

You may not qualify if:

• 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 participants.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu Hospital

Beijing, None Selected, 100053, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Residual cerebrospinal fluid obtained during clinically indicated diagnostic lumbar puncture will be collected after completion of routine clinical testing. Samples will be processed for flow cytometry analysis of mitochondrial content, mitochondrial membrane potential, and membrane-associated markers. The planned flow cytometry panel includes MitoTracker, JC-1, CD45, CD41, CD24, vWF, and EAAT1.

MeSH Terms

Conditions

Ischemic Stroke; Alzheimer Disease

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Dementia; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Xi Chen, MD/PhD

CONTACT

8617600104266; chenxi00cx@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xuanwu Hospital, Capital Medical University

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)