Dopaminergic Mechanism of Memory Impairment in Parkinson's Disease
Dopaminergic Mechanism of Temporal Working Memory Impairment in Parkinson's Disease
1 other identifier
interventional
150
1 country
1
Brief Summary
The cognitive impairment of Parkinson's disease is non amnestic, which is characterized by working memory impairment and executive dysfunction. The current drug therapy (such as levodopa, dopamine receptor agonists) and surgical treatment (such as deep brain electrical stimulation, thalamic lesion) not only can not effectively alleviate cognitive impairment, but also may aggravate cognitive and speech behavior abnormalities. This project will explore how dopamine regulates temporal working memory in human research by combining drug intervention, neuroimaging and cognitive tasks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 parkinson-disease
Started Jan 2018
Longer than P75 for phase_4 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 27, 2021
CompletedFirst Posted
Study publicly available on registry
July 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJuly 20, 2021
June 1, 2021
4 years
June 27, 2021
July 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of cognition function
The score of MontrealCognitiveAssessment(MoCA),ranging from 0-30,with higher socre means better outcome
12 months after the trail
Secondary Outcomes (2)
Task state fMRI scanning
Before drug treatment
Task state fMRI scanning
4 weeks after receiving drug treatment
Study Arms (3)
Madopar monotherapy group
EXPERIMENTALPatients in this group received Madopar monotherapy
senfrol monotherapy group
ACTIVE COMPARATORPatients in this group were treated with senfrol (D2 receptor agonist) alone
placebo group
PLACEBO COMPARATORPatients in this group were treated with selegiline alone
Interventions
In addition to basic treatment, the patient also received Madopar treatment
In addition to the basic treatment, the patient also received the rofosson treatment
In addition to basic treatment, the patient also received selegiline treatment
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking University Third Hospitallead
- Chinese Academy of Sciencescollaborator
Study Sites (1)
Peking University Third Hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yingshuang Zhang
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2021
First Posted
July 20, 2021
Study Start
January 1, 2018
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
July 20, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share