Parkinson's disease
Conditions
Interventions
Experimental group:From the 1st day to the 26th week, olacetam capsules 2 tablets/time, twice a day
Control group:From the 1st day to the 26th week, Placebo capsules 2 tablets/time, twice a day
Sponsors
The Second Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
41 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age > 40 years old, =75 years old, no gender limitation; 2. =6 years of formal education; 3. Meet the diagnostic criteria of Parkinson's disease in China (2016 edition); 4. Meet the criteria for diagnosing mild cognitive impairment in Parkinson's disease (2012 edition), or the criteria for diagnosing Dementia in Parkinson's disease (2007 edition), developed by the International Movement Disorders Association; 5. For Parkinson's disease with mild cognitive impairment or mild to moderate dementia, MMSE=11, CDR=2; 6. HAMD score of Hamilton Depression Scale =17; 7. The patient agrees to participate in the study, and he/she or his/her legally significant guardian signs an informed consent before the study; 8. Dementia patients have caregivers with education level =6 years, and the MMSE score of caregivers should be within the following range: 6 years of education > 20 points, more than 6 years of education > 24 points. Accompany patients at least 4 days per week for more than 4 hours per day and accompany patients to every visit.
Exclusion criteria
Exclusion criteria: 1. Cognitive impairment caused by encephalopathy other than Parkinson's disease (such as Alzheimer's disease, Lewy body dementia, frontotemporal dementia, demyelinating disease of central nervous system, tumor, hydrocephalus, trauma, syphilis, AIDS, Creutzfeldt-Jakob disease, etc.). If MRI shows the presence of ischemic cerebrovascular disease, the White matter Injury Rating Scale (Fazekas) should be = grade 1 to exclude the patients with vascular dementia and cognitive impairment in Parkinson's disease to the maximum extent. 2. Patients with severe neurological impairment who cannot complete the examination, such as convenient hemiplegia, aphasia, audio-visual impairment, etc.; 3. Unable to swallow oral drugs, or suffering from diseases that affect oral drug absorption, such as active bowel disease, partial or complete intestinal obstruction, etc.; 4. Serious circulatory, respiratory, urinary, digestive and hematopoietic diseases (such as unstable angina, uncontrolled asthma, active gastric bleeding, etc.) and cancer; 5. Diseases of nutritional metabolism and diseases of the endocrine system: diseases of the thyroid gland, diseases of the parathyroid gland, deficiency of vitamins or other elements; 6. Severe mental illness (such as depression, schizophrenia) and epilepsy; 7. Alcohol and drug abuse; 8. Family history of dementia; 9. Used drugs that affect cognitive function, such as cholinesterase inhibitors, memantine, cholinomimetic drugs, antipsychotics, antianxiety drugs, hypnotics, and prophylaxis drugs (including traditional Chinese herbs and pills) in the previous month; 10. Patients who had used Olacetam injection or Olacetam capsule two weeks before enrollment; 11. Allergic to Olacetam; 12. Patients with severe bleeding tendency and liver dysfunction (transaminase exceeding 3 times the upper limit of normal value); 13. Pregnant and lactating women; 14. Participated in other interventional clinical investigators within 3 months prior to enrollment; 15. Patients unable to undergo MRI cranial imaging examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in cognitive functionl; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall evaluation: Impressions of changes in the condition during clinical doctor interviews;Overall cognitive ability;Improvement of daily living abilities;Improvement of Neuropsychiatric Behavior;Laboratory indicators: EEG background rhythm, slow wave power, serum uric acid, homocysteine, blood lipids, bilirubin levels, peripheral blood inflammatory factor levels; 13. 26 weeks of peripheral blood T cell differentiation and gas molecular biomarkers; | — |
Countries
China
Contacts
Public ContactLiang Wang
The Second Hospital of Hebei Medical University
Outcome results
None listed