Early diagnosis of Parkinson's using digital and neurogenic exosome biomarkers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will use multi-dimensional wearable technology and machine learning to screen digital biomarkers in prodromal PD, early PD, and healthy cohorts. They will also analyze blood samples with peptide nanoprobes, metabolomics, and Simoa to identify high-purity neurogenic exosome biomarkers associated with early PD. An association analysis will explore how digital and molecular biomarkers relate, with the goal of building a fusion model that combines digital phenotype markers and molecular biomarkers for early PD diagnosis. The study design is observational and focuses on three participant groups to develop and test biomarker-based classification approaches. No intervention is described beyond biomarker discovery and analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Healthy Control Group

  1. No severe mental illness;
  2. Mini-Mental State Examination (MMSE) score \>24 points; 2. Prodromal PD Group

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  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.

Where it's running

• Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: qinyong ye
• Email: unionqyye@163.com
• Phone: 13365910205

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.