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Dopaminergic Mechanism of Memory Impairment in Parkinson's Disease

Primary Purpose

Parkinson Disease, Memory Impairment

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Madopar monotherapy
senfrol monotherapy
placebo monotherapy
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Madopar monotherapy group

senfrol monotherapy group

placebo group

Arm Description

Patients in this group received Madopar monotherapy

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

Patients in this group were treated with selegiline alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Task state fMRI scanning
Task state fMRI scanning

Full Information

First Posted
June 27, 2021
Last Updated
July 8, 2021
Sponsor
Peking University Third Hospital
Collaborators
Chinese Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04968613
Brief Title
Dopaminergic Mechanism of Memory Impairment in Parkinson's Disease
Official Title
Dopaminergic Mechanism of Temporal Working Memory Impairment in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Chinese Academy of Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Memory Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Madopar monotherapy group
Arm Type
Experimental
Arm Description
Patients in this group received Madopar monotherapy
Arm Title
senfrol monotherapy group
Arm Type
Active Comparator
Arm Description
Patients in this group were treated with senfrol (D2 receptor agonist) alone
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Patients in this group were treated with selegiline alone
Intervention Type
Drug
Intervention Name(s)
Madopar monotherapy
Intervention Description
In addition to basic treatment, the patient also received Madopar treatment
Intervention Type
Drug
Intervention Name(s)
senfrol monotherapy
Intervention Description
In addition to the basic treatment, the patient also received the rofosson treatment
Intervention Type
Drug
Intervention Name(s)
placebo monotherapy
Intervention Description
In addition to basic treatment, the patient also received selegiline treatment
Primary Outcome Measure Information:
Title
Evaluation of cognition function
Description
The score of MontrealCognitiveAssessment(MoCA),ranging from 0-30,with higher socre means better outcome
Time Frame
12 months after the trail
Secondary Outcome Measure Information:
Title
Task state fMRI scanning
Time Frame
Before drug treatment
Title
Task state fMRI scanning
Time Frame
4 weeks after receiving drug treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingshuang Zhang
Phone
18511650863
Email
zhangys0317@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingshuang Zhang
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingshuang Zhang
Phone
18511650863

12. IPD Sharing Statement

Plan to Share IPD
No

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Dopaminergic Mechanism of Memory Impairment in Parkinson's Disease

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