Dopaminergic Mechanism of Memory Impairment in Parkinson's Disease

Peking University

Status and phase: Unknown; Phase 4

Conditions: Parkinson Disease; Memory Impairment

Treatments: Drug: senfrol monotherapy; Drug: placebo monotherapy; Drug: Madopar monotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04968613

M2017368

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups, including a placebo group

Madopar monotherapy group

Experimental group

Description:

Patients in this group received Madopar monotherapy

Treatment:

Drug: Madopar monotherapy

senfrol monotherapy group

Active Comparator group

Description:

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

Treatment:

Drug: senfrol monotherapy

placebo group

Placebo Comparator group

Description:

Patients in this group were treated with selegiline alone

Treatment:

Drug: placebo monotherapy