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Cerebrospinal Fluid Mitochondrial Biomarkers in Ischemic Stroke and Alzheimer Disease

4 september 2026 uppdaterad av: Ji Xunming,MD,PhD, Capital Medical University

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Mitochondrial dysfunction is closely associated with ischemic brain injury, but the clinical relevance of extracellular or cell-associated mitochondrial signals in the cerebrospinal fluid of patients with ischemic stroke remains insufficiently characterized. Cerebrospinal fluid may provide a biologically informative compartment for assessing mitochondrial injury, mitochondrial membrane potential, and potential cellular sources of mitochondrial signals in neurological diseases.

This is a single-center, prospective, observational study conducted at Xuanwu Hospital, Capital Medical University. The study will enroll patients with ischemic stroke or Alzheimer disease who require diagnostic lumbar puncture as part of routine clinical evaluation between March 2026 and May 2026. No lumbar puncture will be performed solely for research purposes. After completion of clinically required testing, available residual cerebrospinal fluid will be collected for research flow cytometry analysis.

Flow cytometry will be used to evaluate cerebrospinal fluid mitochondrial content and related phenotypic features. MitoTracker will be used to detect mitochondrial signal, JC-1 will be used to assess mitochondrial membrane potential, and membrane-associated markers including CD45, CD41, CD24, vWF, and EAAT1 will be used to characterize potential leukocyte-associated, platelet-associated, neuronal/extracellular vesicle-associated, endothelial-associated, and astrocytic/glial-associated components.

The primary analysis will focus on patients with ischemic stroke and will evaluate the association between cerebrospinal fluid mitochondrial content and 90-day functional outcome measured by the modified Rankin Scale. Secondary analyses will examine associations between cerebrospinal fluid mitochondrial measurements and admission NIHSS, discharge NIHSS, and changes in NIHSS during hospitalization. Exploratory analyses will compare cerebrospinal fluid mitochondrial and membrane-marker profiles between ischemic stroke patients and Alzheimer disease controls.

Studietyp

Observationell

Inskrivning (Faktisk)

40

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Kina
    • None Selected
      • Beijing, None Selected, Kina, 100053
        • Xuanwu Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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 participants.

Any condition judged by the investigator to make the participant unsuitable for inclusion in the study.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Diagnostiskt test: Cerebrospinal Fluid Flow Cytometry
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
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.
Diagnostiskt test: Cerebrospinal Fluid Flow Cytometry
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and 90-Day Modified Rankin Scale Score in Patients With Ischemic Stroke
Tidsram: Day 90 after stroke onset
The primary outcome is the association between cerebrospinal fluid (CSF) MitoTracker-positive event count measured at baseline and functional outcome assessed by the modified Rankin Scale (mRS) on Day 90 after stroke onset. The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.
Day 90 after stroke onset

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Association Between Cerebrospinal Fluid MitoTracker Median Fluorescence Intensity and 90-Day Modified Rankin Scale Score in Patients With Ischemic Stroke
Tidsram: Day 90 after stroke onset
The association between cerebrospinal fluid (CSF) MitoTracker median fluorescence intensity measured at baseline and 90-day modified Rankin Scale (mRS) score will be assessed in patients with ischemic stroke.
Day 90 after stroke onset
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and Baseline National Institutes of Health Stroke Scale Score
Tidsram: Baseline, within 24 hours after hospital admission
The association between cerebrospinal fluid (CSF) MitoTracker-positive event count measured at baseline and neurological deficit severity will be assessed using the National Institutes of Health Stroke Scale (NIHSS) score obtained within 24 hours after hospital admission. Higher NIHSS scores indicate more severe neurological impairment.
Baseline, within 24 hours after hospital admission
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and Discharge National Institutes of Health Stroke Scale Score
Tidsram: At hospital discharge, up to 30 days after hospital admission
The association between cerebrospinal fluid (CSF) MitoTracker-positive event count measured at baseline and neurological deficit severity at discharge will be assessed using the National Institutes of Health Stroke Scale (NIHSS) score recorded at hospital discharge.
At hospital discharge, up to 30 days after hospital admission
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and Change in National Institutes of Health Stroke Scale Score During Hospitalization
Tidsram: From baseline within 24 hours after hospital admission to hospital discharge, up to 30 days after hospital admission
Change in National Institutes of Health Stroke Scale (NIHSS) score will be calculated as the discharge NIHSS score minus the baseline NIHSS score obtained within 24 hours after hospital admission. The association between cerebrospinal fluid (CSF) MitoTracker-positive event count measured at baseline and change in NIHSS score during hospitalization will be evaluated.
From baseline within 24 hours after hospital admission to hospital discharge, up to 30 days after hospital admission
Cerebrospinal Fluid JC-1 Red-to-Green Fluorescence Ratio
Tidsram: Baseline, at the time of diagnostic lumbar puncture
Mitochondrial membrane potential in cerebrospinal fluid (CSF)-associated mitochondrial events will be assessed using JC-1 dye by flow cytometry. The JC-1 red-to-green fluorescence ratio will be used as a measure of mitochondrial polarization status.
Baseline, at the time of diagnostic lumbar puncture
Difference in Cerebrospinal Fluid MitoTracker-Positive Event Count Between Patients With Ischemic Stroke and Alzheimer Disease Controls
Tidsram: Baseline, at the time of diagnostic lumbar puncture
Cerebrospinal fluid (CSF) MitoTracker-positive event count will be compared between patients with ischemic stroke and Alzheimer disease controls at baseline.
Baseline, at the time of diagnostic lumbar puncture

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing Cluster of Differentiation 45
Tidsram: Baseline, at the time of diagnostic lumbar puncture
The percentage of cerebrospinal fluid (CSF) MitoTracker-positive events expressing cluster of differentiation 45 (CD45) will be measured by flow cytometry to characterize leukocyte-associated mitochondrial events.
Baseline, at the time of diagnostic lumbar puncture
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing Cluster of Differentiation 41
Tidsram: Baseline, at the time of diagnostic lumbar puncture
The percentage of cerebrospinal fluid (CSF) MitoTracker-positive events expressing cluster of differentiation 41 (CD41) will be measured by flow cytometry to characterize platelet-associated mitochondrial events.
Baseline, at the time of diagnostic lumbar puncture
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing Cluster of Differentiation 24
Tidsram: Baseline, at the time of diagnostic lumbar puncture
The percentage of cerebrospinal fluid (CSF) MitoTracker-positive events expressing cluster of differentiation 24 (CD24) will be measured by flow cytometry to characterize CD24-positive mitochondrial events.
Baseline, at the time of diagnostic lumbar puncture
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing von Willebrand Factor
Tidsram: Baseline, at the time of diagnostic lumbar puncture
The percentage of cerebrospinal fluid (CSF) MitoTracker-positive events expressing von Willebrand factor (vWF) will be measured by flow cytometry to characterize endothelial-associated mitochondrial events.
Baseline, at the time of diagnostic lumbar puncture
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing Excitatory Amino Acid Transporter 1
Tidsram: Baseline, at the time of diagnostic lumbar puncture
The percentage of cerebrospinal fluid (CSF) MitoTracker-positive events expressing excitatory amino acid transporter 1 (EAAT1) will be measured by flow cytometry to characterize astrocytic or glial-associated mitochondrial events.
Baseline, at the time of diagnostic lumbar puncture

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Capital Medical University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 mars 2026

Primärt slutförande (Faktisk)

31 maj 2026

Avslutad studie (Faktisk)

30 augusti 2026

Studieregistreringsdatum

Först inskickad

15 maj 2026

Först inskickad som uppfyllde QC-kriterierna

15 maj 2026

Första postat (Faktisk)

22 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CSF-MITO

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

The study is proceeding.

Läkemedels- och apparatinformation, studiedokument

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Nej

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