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Integrated Digital and Neurogenic Exosome Biomarkers for Early Diagnosis of Parkinson's Disease: Development and Application

25. juni 2026 opdateret af: Fujian Medical University Union Hospital
Based on the high-quality Parkinson's disease cohort population and biological sample database in the early stage of the team, multi-dimensional intelligent wearable device technology and machine learning were used to screen and classify digital biomarkers in the prodromal PD cohort, early PD cohort and healthy population cohort. Using peptide nanoprobes, metabolomics and Simoa technology to find the pathological molecular biomarkers of high-purity blood neurogenic exosomes in the prodromal stage of PD cohort, early PD cohort and healthy population cohort, and conduct classification and combination study. The association analysis was used to explore the specific internal relationship between digital biomarkers and neurogenic exosome molecular biomarkers, to explore the potential relationship between the two types of biomarkers, and to further apply machine learning methods to establish a fusion model for early diagnosis of PD including markers related to digital phenotype and pathological molecular mechanism, and to verify it clinically. The research results of this project are expected to bring new strategies for the early diagnosis of PD biomarkers, provide theoretical support for clinical transformation, and have important clinical significance for achieving the goal of early diagnosis and early treatment.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

700

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Fujian
      • Fuzhou, Fujian, Kina, 350000
        • Rekruttering
        • Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital
        • Kontakt:
          • Department of Neurology, Fujian Institute of Geriatrics, Fujia Department of Neurology, Fujian Institute of Geriatrics, Fujia
          • Telefonnummer: +86 591 8621 8329

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

This study comprises a combined retrospective and prospective cohort of patients with idiopathic Parkinson's disease (PD), selected from the PD registry database maintained by our team at Fujian Medical University Union Hospital. The study population includes individuals who meet all of the following criteria: (1) diagnosed with idiopathic PD based on the Movement Disorder Society (MDS) clinical diagnostic criteria; (2) Hoehn-Yahr (H-Y) stage ≤ 2.0 during off-medication periods; and (3) Mini-Mental State Examination (MMSE) score > 24 points. Eligible participants will be identified from the existing database for retrospective data collection, while prospective follow-up data will be collected for the same cohort to enable comprehensive longitudinal analyses.

Beskrivelse

Inclusion Criteria:

  • 1. Healthy Control Group

    1. No severe mental illness;
    2. Mini-Mental State Examination (MMSE) score >24 points; 2. Prodromal PD Group
    1. Meets the diagnostic criteria for rapid eye movement sleep behavior disorder;
    2. Has no severe mental disorders;
    3. Mini-Mental State Examination (MMSE) score is greater than 24 points. 3. Early PD Group

    (1) Diagnosed with idiopathic Parkinson's disease based on the MDS clinical diagnostic criteria ; (3) Hoehn-Yahr (H-Y) stage <=2.0 during off-medication periods; (4) Mini-Mental State Examination (MMSE) score >24 points;

Exclusion Criteria:

  1. Presence of mental, cognitive, or psychological disorders, unable to sign informed consent;
  2. Presence of other diseases affecting walking distance, such as lower limb joint lesions, spinal lesions, neurological disorders, or severe cardiopulmonary diseases;
  3. Presence of intracranial structural changes, cerebrovascular disease, or other neurological disorders;
  4. Presence of tumors, severe liver or kidney dysfunction (indicators exceeding three times the normal value), or other conditions that significantly impact health;
  5. Claustrophobia or presence of implants affecting MRI scanning.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Sundhedskontrol
PD prodromal group
Early PD group

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mini-mental State Examination
Tidsramme: baseline
Mini-Mental State Examination (MMSE) is a 30-item cognitive screening tool assessing orientation, memory, attention, calculation, and language, with total scores ranging from 0 to 30. Higher scores indicate better cognitive function. Scores ≥27 generally indicate normal cognition, while lower scores suggest varying degrees of impairment, with cutoffs adjusted for education and age.
baseline
Montreal Cognitive Assessment
Tidsramme: baseline
Montreal Cognitive Assessment (MoCA) is a 10-15 minute screening tool covering 8 cognitive domains through 12 tasks, with total scores ranging from 0 to 30. Higher scores indicate better cognitive function. Scores ≥26 are generally considered normal, with a 1-point adjustment for education ≤12 years; scores <26 suggest possible cognitive impairment.
baseline
The 39-Item Parkinson's Disease Questionnaire
Tidsramme: baseline
Non-Motor Symptoms Scale (NMSS) assesses frequency and severity of non-motor symptoms across all stages of Parkinson's disease, covering autonomic, affective, cognitive, sleep, and other domains. Total scores range from 0 to 360. Higher scores indicate worse outcome (greater symptom burden).
baseline
Hamilton Depression Rating Scale
Tidsramme: baseline
Hamilton Depression Rating Scale (HAM-D) is a clinician-rated instrument assessing depression severity across multiple dimensions including mood, somatic symptoms, anxiety, and sleep disturbance. The 17-item version (HAM-D17) yields total scores ranging from 0 to 52. Higher scores indicate worse outcome (greater depressive symptom severity), with scores ≥23 indicating very severe depression.
baseline
hoehn-yahr stage
Tidsramme: baseline
Hoehn and Yahr Scale (HY) is a clinician-rated instrument assessing clinical severity and disease staging in Parkinson's disease. Staging ranges from 0 (no symptoms) to 5 (severe disability requiring full dependence). Higher stages indicate worse outcome (more advanced disease with greater functional impairment), primarily based on postural instability and disability.
baseline
Movement Disorder Society-Sponsored Revision Of The Unified Parkinson's Disease Rating Scale
Tidsramme: baseline
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive instrument assessing Parkinson's disease across four parts: non-motor symptoms, activities of daily living, motor symptoms, and complications. Total scores range from 0 to 260 (Part I: 0-52, Part II: 0-52, Part III: 0-132, Part IV: 0-24). Higher scores indicate worse outcome (greater impairment).
baseline
Wearable devices measure gait parameters
Tidsramme: baseline
Wearable Device System (GYENNO MATRIX) is a 10-sensor system sampling at 100 Hz to capture 3D angular velocity, acceleration, and geomagnetic field data. It extracts gait parameters (step length, stride, gait cycle) and detects postural transitions (standing, sitting, turning).
baseline
Sniffin' Sticks 12
Tidsramme: baseline
Sniffin' Sticks 12 (SS-12) is a brief olfactory screening test assessing odor identification ability using 12 pen-like odor pens. Total scores range from 0 to 12, based on the number of correctly identified odors. Higher scores indicate better outcome (superior olfactory function). It is widely used for early Parkinson's disease screening and cognitive disorder assessment.
baseline
REM sleep behavior disorderscreening questionnaire
Tidsramme: baseline
REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) is a 10-item self-rated scale screening for REM sleep behavior disorder, covering dream content, dream-enactment behaviors, injuries, and neurological conditions. Total scores range from 0 to 13. Higher scores indicate worse outcome (greater likelihood of abnormality), with scores ≥5 considered abnormal.
baseline
Parkinson's disease sleep scale
Tidsramme: baseline
Parkinson's Disease Sleep Scale (PDSS) is a 15-item scale assessing sleep disturbances in Parkinson's disease, covering nighttime quality, sleep onset, maintenance, limb discomfort, dreaming, hallucinations, nocturia, and daytime sleepiness. Total scores range from 0 to 150 (0-10 per item). Higher scores indicate better outcome (fewer or less severe sleep problems).
baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fujian Medical University Union Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2024

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

22. december 2025

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. december 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026KY647

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med PARKINSON SYGGE (lidelse)

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