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

NCT07679256 | Recruiting DMC

• 1 other identifier: 2026KY647
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PARKINSON DISEASE (Disorder)

Outcome Measures

Primary Outcomes (10)

• Mini-mental State Examination

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (3)

Health control

PD prodromal group

Early PD group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. Healthy Control Group
• No severe mental illness;
• Mini-Mental State Examination (MMSE) score \>24 points; 2. Prodromal PD Group
• <!-- -->
• Meets the diagnostic criteria for rapid eye movement sleep behavior disorder;
• Has no severe mental disorders;
• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

qinyong ye

CONTACT

13365910205; unionqyye@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: July 1, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 1, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)