Dopaminergic Mechanism of Memory Impairment in Parkinson's Disease

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04968613
Collaborator
Chinese Academy of Sciences (Other)
150
1
3
48
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Madopar monotherapy
  • Drug: senfrol monotherapy
  • Drug: placebo monotherapy
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Dopaminergic Mechanism of Temporal Working Memory Impairment in Parkinson's Disease
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Madopar monotherapy group

Patients in this group received Madopar monotherapy

Drug: Madopar monotherapy
In addition to basic treatment, the patient also received Madopar treatment

Active Comparator: senfrol monotherapy group

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

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

Placebo Comparator: placebo group

Patients in this group were treated with selegiline alone

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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of cognition function [12 months after the trail]

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

Secondary Outcome Measures

  1. Task state fMRI scanning [Before drug treatment]

  2. Task state fMRI scanning [4 weeks after receiving drug treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing China

Sponsors and Collaborators

  • Peking University Third Hospital
  • Chinese Academy of Sciences

Investigators

  • Principal Investigator: Yingshuang Zhang, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04968613
Other Study ID Numbers:
  • M2017368
First Posted:
Jul 20, 2021
Last Update Posted:
Jul 20, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021