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临床试验/NCT04968613
NCT04968613Unknown4 期

Dopaminergic Mechanism of Temporal Working Memory Impairment in Parkinson's Disease

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
150
试验地点
1
主要终点
Evaluation of cognition function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Madopar monotherapy group

Experimental

Patients in this group received Madopar monotherapy

干预措施: Madopar monotherapy (Drug)

senfrol monotherapy group

Active Comparator

Patients in this group were treated with senfrol (D2 receptor agonist) alone

干预措施: senfrol monotherapy (Drug)

placebo group

Placebo Comparator

Patients in this group were treated with selegiline alone

干预措施: placebo monotherapy (Drug)

结局指标

主要结局

Evaluation of cognition function

时间窗: 12 months after the trail

The score of MontrealCognitiveAssessment(MoCA),ranging from 0-30,with higher socre means better outcome

次要结局

  • Task state fMRI scanning(4 weeks after receiving drug treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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