PARKINSON DISEASE (Disorder)NCT07679256
Integrated Digital and Neurogenic Exosome Biomarkers for Early Diagnosis of Parkinson's Disease: Development and Application
An observational study of PARKINSON DISEASE (Disorder), run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 1. 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
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Department of Neurology, Fujian Institute of Geriatrics, Fujia Department of Neurology, Fujian Institute of Geriatrics, Fujia, +86 591 8621 8329
About this study
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)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Health control | Not described | |
| PD prodromal group | Not described | |
| Early PD group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679256
- Sponsor's protocol ID
- 2026KY647
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Digital and Neurogenic Exosome Biomarkers for Early Diagnosis of Parkinson's Disease: Development and Application
- ClinicalTrials.gov ID
- NCT07679256
- Acronym / sponsor ID
- 2026KY647
- Conditions
- PARKINSON DISEASE (Disorder)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health control | – | – |
| PD prodromal group | – | – |
| Early PD group | – | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 1. Healthy Control Group
- <!-- -->
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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).
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.
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.
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).
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).
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.
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PARKINSON DISEASE (Disorder), run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qinyong ye (13365910205, unionqyye@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-mental State Examination (time frame: baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.