Integrated Digital and Neurogenic Exosome Biomarkers for Early Diagnosis of Parkinson's Disease: Development and Application
Recruiting · NCT07679256 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fujian Medical University Union Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- 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
- 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.
Where it is running
1 location listed.
- Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital - Fuzhou, Fujian, China