Dopaminergic Mechanism of Memory Impairment in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04968613
• Other study ID #: M2017368
• Status: Recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Memory Disorders
• Memory Impairment
• Parkinson Disease

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