Search / Trial NCT06232772

Research on Novel Biomarkers for Early Diagnosis of Parkinson's Disease

Launched by YOUSHENG XIAO · Jan 22, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to detect early signs of Parkinson's Disease (PD) using a special method that analyzes samples from the body, like saliva, urine, blood, and skin. The researchers want to see how well this method can identify PD in patients who have already been diagnosed, as well as in those with related conditions. The study is currently recruiting participants aged 65 to 74 and 29 to 219 years old, regardless of gender.

To be eligible, participants need to have a confirmed or probable diagnosis of Parkinson's Disease that meets specific criteria set by medical guidelines. Individuals with other types of Parkinsonism or healthy volunteers who match the age and gender of the patients will also be included. Those who choose to participate can expect to provide samples for testing and help contribute to important research aimed at improving the early diagnosis of Parkinson's Disease. It's also essential to note that individuals with severe cognitive issues or certain other medical conditions won't be eligible to take part in this study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with clinically defined or probable PD:According to the 2015 MDS diagnostic criteria, patients diagnosed with "clinically confirmed PD" regardless of age, gender, and meeting Hoehn\&Yahr staging ≤ 2.5 were included as case group one, which met \[Parkinson's syndrome+at least two supportive criteria+no absolute exclusion criteria\]
  • Patients with clinically probable PD:According to the 2015 MDS diagnostic criteria, patients diagnosed with "clinically probable PD", regardless of age or gender, and meeting Hoehn\&Yahr staging ≤ 2.5 were included as case group two, i.e. patients who met \[Parkinson's syndrome+no absolute exclusion criteria+1/2 supportive criteria+1/2 warning signs\]
  • MSA group:Adult onset (\>30 years old), sporadic and progressive development, and possessing the following characteristics: 1 Has one of the following two conditions: ① Parkinson's syndrome with levodopa adverse response (bradykinesia, accompanied by muscle rigidity, tremors, or postural instability), ② cerebellar dysfunction: gait ataxia, accompanied by cerebellar articulation disorders, limb ataxia, or cerebellar eye movement disorders; 2. At least one manifestation of autonomic dysfunction is present: ① urinary incontinence (inability to control bladder urination, male with erectile dysfunction), ② orthostatic hypotension (a decrease in systolic blood pressure of ≥ 30mmHg and/or diastolic blood pressure of ≥ 15mmHg after standing for 3 minutes).
  • PSP group:Clinical diagnosis and likely PSP included in the Chinese progressive supranuclear palsy clinical diagnostic criteria developed by the Parkinson's disease and motor disorders group of the Neurology Branch of the Chinese Medical Association in 2016;
  • Healthy subjects:Healthy population matched with age and gender in the experimental group In addition to the selected patients, a study will also be conducted on patient data in the reference database of the proposing institution.
  • Exclusion Criteria:
  • Patients who do not consent to study participation
  • Secondary Parkinson's syndrome caused by vascular factors, drugs, etc
  • Severe cognitive impairment, AD, amyotrophic lateral sclerosis and other neurodegenerative diseases

Trial Officials

Yousheng Xiao, Professor

Principal Investigator

Guangxi Medical University

About Yousheng Xiao

Yousheng Xiao is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on enhancing patient outcomes, the organization collaborates with leading healthcare professionals and institutions to design and conduct rigorous clinical trials. Yousheng Xiao prioritizes ethical standards and regulatory compliance, ensuring the safety and well-being of participants while striving to contribute valuable data to the scientific community. Through a patient-centered approach and a commitment to excellence, Yousheng Xiao aims to facilitate the development of novel therapies and improve healthcare solutions.

Locations

Nanning, Guangxi, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0