Parkinson’s disease
Conditions
Interventions
Gold Standard:Clinically established Parkinson's disease conforming to China Diagnostic Criteria for Parkinson's Disease (2016)
biomarkers 
(miRNA 
and 
a-synuclein)
Sponsors
The First Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
21 Years to 100 Years
Inclusion criteria
Inclusion criteria: (I) Inclusion criteria for Parkinson's disease 1. Aged > 21 years; 2. Can speak Mandarin (or dialect to effectively communicate with doctors); 3. I and my family members sign the informed consent; 4. MMSE 25 or more; 5. According to the diagnostic criteria of Parkinson's disease in China (2016), the patient was diagnosed with Parkinson's disease; 6. Hoehn & Yahr(H&Y) stage 1-4.
Exclusion criteria
Exclusion criteria: Exclusion criteria for Parkinson's disease group 1. Hearing impairment, visual impairment, poor coordination. 2. A lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder. 3. Subjects currently taking antidepressants. Who were currently depressed or had a history of major depression within the last two years. 4. I have had ECT in the past. 5. A history of alcohol abuse or dependence after two years of screening. 6. Long-term history of heavy alcohol consumption (alcohol degree greater than 42 degrees, more than 3 2 / day, drinking more than 12 months). 7. A history of uncontrolled malignancy within one year (including tumors of the nervous system and tumors outside the nervous system) 8. Any serious systemic disease or unstable condition that makes it difficult to comply with the protocol, including: a history of serious pulmonary disease (COPD, pulmonary encephalopathy); History of severe cardiovascular disease (heart failure, severe hypertension). 9. Subjects with the following clinically significant symptoms or history: history of severe nervous system infection of any cause, history of multiple sclerosis, history of immune encephalitis, history of Hashimoto's encephalopathy, etc. Epileptic seizures that are not currently under stable control due to a variety of previous causes; A history of hereditary diseases that may affect cognitive function (e.g. Huntington's disease, Down's syndrome, Cadasil syndrome, adrenoencephalodystrophy, mitochondrial encephalopathy, etc.); Infections and immune-related diseases affecting the central nervous system (systemic lupus erythematosus, undertreated HIV infection or a history of CNS spiralling infection, etc.); Metabolic diseases and endocrine disorders that affect the central nervous system (thyroid dysfunction, folic acid or vitamin B12 deficiency requiring new treatment or modification of current treatment); An epileptic seizure that is currently not under stable control due to a variety of previous causes. 10. Subjects had the following diseases or clinical symptoms: including atypical features of Parkinson's syndrome (progressive supranuclear palsy (PSP), multisystem atrophy (MSA), and cortical basal cell degeneration (CBD)), including cerebellar symptoms, supranuclear gaze-palsy, apraxia and other cortical symptoms, or prominent autonomic nervous failure. 11. A history of clinically significant and unstable gastrointestinal diseases, including ulcers and severe or latent gastrointestinal bleeding, has been reported in the past two years. 12. Exclusion criteria related to systemic diseases affecting nervous system function, abnormal liver and kidney function (abdominal dialysis or hemodialysis during the screening period; AST or ALT >= 3 x upper limit of normal value (ULN) or total bilirubin >= 2 x ULN in screening period. 13. Uncontrolled diabetes; 14. A history of unstable malignancy (including tumors of the nervous system and tumors outside the nervous system) was reviewed within 1 year. 15. Drugs excluded from the study included: 1) Use of narcotic drugs, methyldopa and clonidine in the 4 weeks prior to screening; 2) In the 4 weeks before screening, short-term anti-anxiety drugs or sedative hypnotics should be used more than twice a week (Note: sedative drugs should not be used within 72 hours after screening); 3) Systemic corticosteroid use within 3 months prior to screening; 4) Use of anticonvulsants (such as phenytoin, phenobarbital, carbama
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exosome miRNA;Exosome a-synuclein; | — |
Countries
China
Contacts
Public ContactPei Zhong
The First Affiliated Hospital, Sun Yat-sen University
Outcome results
None listed