Parkinson's disease with cognitive impairment
Conditions
Interventions
Control group:Other anti-dementia drugs
Experimental group:GV971
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the latest diagnostic criteria for MDS Parkinson's disease (2015); 2. Presence of cognitive impairment (mild or severe cognitive impairment); mild cognitive impairment is defined as a decrease in cognitive function from the previous baseline in at least one cognitive domain, and normal or mild impairment of instrumental activities of daily living . Severe cognitive impairment was defined as impairment in at least 2 cognitive domains severe enough to interfere with the subject's activities of daily living; 3. Aged 50-75 years, gender is not limited; 4. Voluntarily sign the informed consent; 5. The total score of modified Hachinski ischemic scale (HIS) is less than or equal to 6 points; 6. Hamilton depression scale (HAMD) total score <= 17 points; 7. The patients agree to participate in this trial, and they or their legal guardians sign the informed consent form before the trial.
Exclusion criteria
Exclusion criteria: 1. Dementia caused by other brain diseases other than Parkinson's disease (such as vascular dementia, Alzheimer's disease, Lewy body dementia, frontotemporal dementia, central nervous system demyelinating disease, tumor, hydrocephalus, trauma, syphilis, AIDS, Creutzfeldt-Jakob disease, etc.); 2. Those with severe neurological deficits who cannot complete the examination, such as hand hemiplegia, various aphasia, audio-visual impairment, etc.; 3. Those who cannot swallow oral drugs, or have diseases that affect the absorption of oral drugs, such as active bowel disease, partial or complete intestinal obstruction, etc.; 4. Severe circulatory, respiratory, urinary, digestive, hematopoietic diseases (such as unstable angina, uncontrolled asthma, active gastric bleeding, etc.) and cancer; 5. Nutritional metabolic diseases and endocrine system diseases: thyroid disease, parathyroid disease and vitamin or other element deficiency; 6. Severe mental illness (such as depression, schizophrenia) and epilepsy; 7. Alcohol and drug abuse; 8. Use of drugs that affect cognitive function within 1 month before the start of this study, such as: cholinesterase inhibitors, memantine, cholinergic drugs, antipsychotics, anxiolytics, hypnotics, nootropics (including traditional Chinese herbs and pills, such as Cistanche Yizhi Capsule, Jiannaoan, etc.); 9. Those with severe bleeding tendency and liver dysfunction (transaminase exceeding 3 times the upper limit of normal); 10. Participated in other interventional clinical studies within 3 months before enrollment; 11. Those who cannot accept MR examination; 12. Other researchers believe that it is not suitable to participate in this research.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Alpha synuclein;Th1 cell;Th1,Th2,Th17,Treg cell;Intestinal microbiota metabolites;Homocysteine; | — |
Primary
| Measure | Time frame |
|---|---|
| Neurofilament light chain; | — |
Countries
China
Contacts
Public ContactWang Qing
Zhujiang Hospital of Southern Medical University
Outcome results
None listed