Dopaminergic Mechanism of Memory Impairment in Parkinson's Disease

NCT ID: NCT04968613

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-12-31

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.

Detailed 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.

Conditions

Parkinson Disease; Memory Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Madopar monotherapy group

Patients in this group received Madopar monotherapy

Group Type: EXPERIMENTAL

Madopar monotherapy

Intervention Type: DRUG

In addition to basic treatment, the patient also received Madopar treatment

senfrol monotherapy group

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

Group Type: ACTIVE_COMPARATOR

senfrol monotherapy

Intervention Type: DRUG

In addition to the basic treatment, the patient also received the rofosson treatment

placebo group

Patients in this group were treated with selegiline alone

Group Type: PLACEBO_COMPARATOR

placebo monotherapy

Intervention Type: DRUG

In addition to basic treatment, the patient also received selegiline treatment

Interventions

Madopar monotherapy

In addition to basic treatment, the patient also received Madopar treatment

Intervention Type: DRUG

senfrol monotherapy

In addition to the basic treatment, the patient also received the rofosson treatment

Intervention Type: DRUG

placebo monotherapy

In addition to basic treatment, the patient also received selegiline treatment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yingshuang Zhang

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yingshuang Zhang

Role: CONTACT

zhangys0317@126.com

18511650863

Facility Contacts

Yingshuang Zhang

Role: primary

18511650863

Other Identifiers

M2017368

Identifier Type: -

Identifier Source: org_study_id