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

June 25, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital
        • Contact:
          • Department of Neurology, Fujian Institute of Geriatrics, Fujia Department of Neurology, Fujian Institute of Geriatrics, Fujia
          • Phone Number: +86 591 8621 8329

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Health control
PD prodromal group
Early PD group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mini-mental State Examination
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026KY647

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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