Parkinson's disease
Conditions
Interventions
Butylphthalide group:Butylphthalide, 2 capsules/time, 3 times/day, for 48 weeks
Control group:Placebo, 2 capsules/time, 3 times/day, for 48 weeks
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Parkinson's disease clinically diagnosed in accordance with the 2015 International Society for the Study of Sports Disorders (MDS) clinical diagnostic criteria; (2) Patients with PD cognitive dysfunction who meet the 2012 version of the PD-MCI diagnostic criteria; (3) DBS operation (surgical target is bilateral STN), patients with preoperative MOCA score > 26 points, postoperative MOCA score 20-25 points; Or non-surgical PD cognitive dysfunction patients with MOCA as a screening index, 20-25 points into the group (4) Aged 18 to 80 years old; (5) H-Y classification <=4; (6) Non-DBS surgery group received stable dopaminergic drug treatment before enrollment; (7) Do not take anti-Parkinson's disease drugs that can significantly affect cognitive function such as memantine, rivastigmine, huperzine A, donepezil, trihexyphenidate, etc. If the above drugs have been used, they need to be discontinued for 2 weeks; (8) The patient has the ability to answer or cooperate with a series of scales or questionnaires involved in the study; (9) An informed consent has been signed by the patient himself/herself before the study.
Exclusion criteria
Exclusion criteria: (1) Secondary Parkinson's syndrome or Parkinson's superposition syndrome caused by vascular factors, toxins, drugs, etc.; (2) Taking butylphthalide within 30 days before enrollment; (3) Those who have suffered severe brain trauma or have undergone complicated craniotomy within 5 years before enrollment; (4) Cognitive disorders of non-Parkinson's syndrome spectrum such as Alzheimer's disease, frontotemporal dementia, and Niemann-Pick disease have been diagnosed; (5) According to DSM-V, diagnosed with severe neuropsychiatric diseases (epilepsy, bipolar disorder, severe depressive episode, etc.); (6) Combined with severe systemic diseases, disturbance of consciousness, stroke, severe coronary heart disease, diabetes, liver and kidney disease, and severe vision and hearing impairment; (7) Those with severe organic or functional dysphagia; (8) Those who are allergic or intolerant to butylphthalide (NBP) at present or in the past; (9) The investigator believes that the visitor and assistant examiner cannot be completed according to the research plan requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MMSE;MoCA; | — |
Secondary
| Measure | Time frame |
|---|---|
| MDS-UPDRS part III, IV;SCOPA-Cog;PDQ-39;CGI-I;HAMD;PDSS; | — |
Countries
China
Contacts
Public ContactWang Tao
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed