NCT05513794

Brief Summary

In order to develop an image analysis system that automatically detects and quantifies neuromelanin, this study aims to construct a database of a wide sample by collecting brain MRI neuromelanin images prospectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2024

Completed
Last Updated

July 28, 2025

Status Verified

July 1, 2024

Enrollment Period

1.7 years

First QC Date

August 22, 2022

Last Update Submit

July 24, 2025

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Differences in Neuromelanin Volume by Age

    Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age

    Within 1 weeks after enrollment

Secondary Outcomes (1)

  • Differences in Neuromelanin Volume by group

    Within 1 weeks after enrollment

Study Arms (2)

Patient group

EXPERIMENTAL

Patient with parkinson disease

Device: MRI Imaging

Healthy volunteer group

EXPERIMENTAL

Healthy volunteer

Device: MRI Imaging

Interventions

MRI ImagingDEVICE

Neuromelanin sequence imaging

Healthy volunteer groupPatient group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults over 19 years old
  • Those who have clinically shown Parkinson's symptoms such as tremor, Rigidity, Bradykinesa and gait disturbance and are scheduled to take MRI scans
  • Dopamine transporter imaging shows a significant decrease in visual dopamine intake
  • A person who can read and understand the description and informed consent form
  • Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions

You may not qualify if:

  • Patient with a history of claustrophobia and mental illness;
  • Patient with metallic substances in the body
  • Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period
  • Pregnant or lactating women
  • Other cases where the investigator judged that it is difficult to participate in the study;
  • Healthy volunteer group
  • Adults over 19 years old
  • A person who has no family history or diagnostic history of movement disorders;
  • A person with a score of 8 or higher on the CCSIT(cross cultural smell identification test)
  • A person with a score of 27 or higher on the MMSE Test
  • No Parkinson's symptoms on a neurological examination
  • Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions
  • Patient with a history of central nervous system disease or cognitive disorder
  • Patient with a history of claustrophobia and mental illness;
  • Patient with metallic substances in the body
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Inje University Sanggye Paik Hospital

Seoul, nowon-gu, 01757, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, Seodaemun gu, 03722, South Korea

Location

Yong-in Severance Hospital, Yonsei University Health System

Gyeonggi-do, yongin-si, 16995, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Phil Hyu Lee, M.D.pH.D

    Severance Hospital, Yonsei University Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 24, 2022

Study Start

November 2, 2022

Primary Completion

July 2, 2024

Study Completion

July 2, 2024

Last Updated

July 28, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(3)