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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

Clinical efficacy of dopamine agonist Pramipexol in the treatment of cognitive impairment in PATIENTS with PD-RBD and its population pharmacokinetic study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037624
Enrollment
Unknown
Registered
2020-08-29
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

experimental group:Pramipexol + dopa hydrazine combination therapy
control group: dopa hydrazine

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Cognitive assessment;

Secondary

MeasureTime frame
Evaluation of disease condition and curative effect;Adverse reactions;Serum inflammatory factors;

Countries

China

Contacts

Public ContactZhou Yan

Shanghai General Hospital

nyyxzy@163.com+86 15900666209

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026