NCT04968613

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_4 parkinson-disease

Timeline
Completed

Started Jan 2018

Longer than P75 for phase_4 parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 20, 2021

Status Verified

June 1, 2021

Enrollment Period

4 years

First QC Date

June 27, 2021

Last Update Submit

July 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Task state fMRI scanning

    Before drug treatment

  • Task state fMRI scanning

    4 weeks after receiving drug treatment

Study Arms (3)

Madopar monotherapy group

EXPERIMENTAL

Patients in this group received Madopar monotherapy

Drug: Madopar monotherapy

senfrol monotherapy group

ACTIVE COMPARATOR

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

Drug: senfrol monotherapy

placebo group

PLACEBO COMPARATOR

Patients in this group were treated with selegiline alone

Drug: placebo monotherapy

Interventions

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

Madopar monotherapy group

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

senfrol monotherapy group

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

placebo group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseMemory Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yingshuang Zhang

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingshuang Zhang

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 20, 2021

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

July 20, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations