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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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2 November 2020 |
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Main ID: |
ChiCTR2000037624 |
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Date of registration:
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2020-08-29 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical efficacy of dopamine agonist Pramipexol in the treatment of cognitive impairment in PATIENTS with PD-RBD and its population pharmacokinetic study
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Scientific title:
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Clinical efficacy of dopamine agonist Pramipexol in the treatment of cognitive impairment in PATIENTS with PD-RBD and its population pharmacokinetic study |
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Date of first enrolment:
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2020-10-01 |
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Target sample size:
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experimental group:50;control group:50; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=60540 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Zhou Yan
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Address:
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650 Xinsongjiang Road, Songjiang District, Shanghai, China
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Telephone:
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+86 21 37798317 |
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Email:
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nyyxzy@163.com |
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Affiliation:
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Shanghai General Hospital |
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Name:
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Zhou Yan
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Address:
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650 Xinsongjiang Road, Songjiang District, Shanghai, China
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Telephone:
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+86 15900666209 |
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Email:
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nyyxzy@163.com |
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Affiliation:
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Shanghai General Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: From October 2020 to March 2022, 100 pD-RBD patients older than 18 years old were selected and admitted to Parkinson's Disease outpatient department and ward of Neurology Department of Shanghai First People's Hospital.
(1) According to the diagnostic criteria and differential diagnosis of Parkinson's disease and Parkinson's Syndrome, patients with primary PD and RBD were diagnosed;
(2) RBD Screening Questionnaire (RBDSQ) total score >= 6 points;
(3) No ergoid or non-ergoid dopamine receptor agonist was used for treatment;
(4) Basic communication skills, can cooperate with the treatment;
(5) Know the research and sign the consent form.
Exclusion criteria: (1) Patients with dementia, cerebral hemorrhage, and mental disorders;
(2) Patients with severe liver, kidney and cardiac insufficiency;
(3) Various secondary PD syndromes and PD superposition syndromes;
(4) PD patients who are not treated with compound LD preparation or who are not responding to the treatment with compound LD preparation;
(5) Irregular medication or poor compliance.
Age minimum:
18
Age maximum:
85
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's disease
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Intervention(s)
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experimental group:Pramipexol + dopa hydrazine combination therapy;control group: dopa hydrazine;
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Primary Outcome(s)
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Cognitive assessment;
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Secondary Outcome(s)
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Evaluation of disease condition and curative effect;Adverse reactions;Serum inflammatory factors;
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Source(s) of Monetary Support
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Three-year Action Plan for clinical skills and clinical innovation in municipal hospitals of Shenkang Hospital Development Center
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Ethics review
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Status: Approved
Approval date:
Contact:
Zhu Wan
+86 21 37798317
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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