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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04968613
Other study ID # M2017368
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2021

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact Yingshuang Zhang
Phone 18511650863
Email zhangys0317@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Parkinson's disease (PD) is a common neurodegenerative disease in the elderly. The incidence rate of China's disease is 1.7% in the population over 65 years old. The latest research shows that Parkinson's disease is not a simple motor disorder, but a multi organ dysfunction disorder with both motor symptoms and non motor symptoms. With the development of the disease, more than 80% of the PD patients will develop dementia. Different from the amnestic cognitive impairment of Alzheimer's disease, the cognitive impairment of Parkinson's disease is non amnestic, characterized by working memory impairment and executive dysfunction. The current mainstream drug therapy (such as levodopa, dopamine receptor agonists) and surgical treatment (such as deep brain electrical stimulation, thalamic lesion) can not effectively alleviate cognitive impairment, and may even aggravate cognitive and speech behavior abnormalities, We should first understand the neurochemical (molecular) mechanisms of working memory impairment and executive dysfunction in Parkinson's disease. A prospective single blind randomized controlled design was used. Newly diagnosed PD patients were randomly assigned to three treatment groups: Madopar monotherapy group (n = 50), senfrol monotherapy group (n = 50) and placebo group (n = 50). Objective to study the performance of temporal working memory in PD patients and reveal the dopaminergic mechanism of temporal working memory.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - Inclusion criteria for PD patients: age 50-80 years old; Junior high school or above, able to read and sign informed consent; Primary PD has just been diagnosed, Hoehn Yahr grade 1-2.5, and has not received any drug or non drug treatment. The inclusion criteria of healthy control group: age 50-80 years old; Junior high school or above, able to read and sign informed consent. Exclusion Criteria: - The exclusion criteria of PD patients group were confirmed as secondary PD; Mental retardation, dementia or depression; Other neuropsychiatric diseases (such as epilepsy, schizophrenia), cerebrovascular diseases (such as stroke) or brain trauma; Antidepressants were used; History of alcohol dependence or drug abuse; Head MRI examination (such as claustrophobia, implantable medical device) is not allowed. Exclusion criteria of healthy control group: Parkinson's disease symptoms (such as static tremor, bradykinesia, limb stiffness); Mental retardation, dementia or depression; REM sleep behavior disorder; There were symptoms of hypoosmia; Other neuropsychiatric diseases, cerebrovascular diseases or brain trauma; Antidepressants were used; History of alcohol dependence or drug abuse; No head MRI.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Madopar monotherapy
In addition to basic treatment, the patient also received Madopar treatment
senfrol monotherapy
In addition to the basic treatment, the patient also received the rofosson treatment
placebo monotherapy
In addition to basic treatment, the patient also received selegiline treatment

Locations

Country Name City State
China Peking University Third Hospital Beijing

Sponsors (2)

Lead Sponsor Collaborator
Peking University Third Hospital Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Task state fMRI scanning Before drug treatment
Secondary Task state fMRI scanning 4 weeks after receiving drug treatment
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