NCT07679256Recruiting
Integrated Digital and Neurogenic Exosome Biomarkers for Early Diagnosis of Parkinson's Disease: Development and Application
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 700 (estimated)
- First submitted
- 22 Dec 2025
- Start date
- 1 Jan 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Fujian Medical University Union Hospital
- Diseases
- Parkinson disease
- NCT number
- NCT07679256
What you commit to
- Study type: Observational
- Planned participants: 700
- From 1 Jan 2024 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Claustrophobia or presence of implants affecting MRI scanning.
Other illness
- 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;
Who the study is looking for
- 1\. Healthy Control Group
- No severe mental illness;
- Mini-Mental State Examination (MMSE) score \>24 points; 2. Prodromal PD Group
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- 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;
Age in the registry: 40 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.