Parkinson DiseaseNCT05513794
Prospective Study for Neuromelanin Image Analysis
A study testing MRI Imaging in people with Parkinson Disease, run by Heuron Inc. at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- MRI Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 2 Nov 2022to 2 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Adults over 19 years old
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- 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
Who cannot join
- 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
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- 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
- 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;
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Yong-in Severance Hospital, Yonsei University Health System
Gyeonggi-do, yongin-si, 16995
Inje University Sanggye Paik Hospital
Seoul, nowon-gu, 01757
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun gu, 03722
About this study
Official title: Prospective Data Collect Study for Development of Neurimelanin Image Analysis System
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.
- Conditions
- Parkinson Disease
- Being tested
- MRI Imaging
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ImagingDevice
Neuromelanin sequence imaging
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | Patient with parkinson disease Receives: Device: MRI Imaging |
| Healthy volunteer group | Experimental | Healthy volunteer Receives: Device: MRI Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Neuromelanin Volume by Age
Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age
Measured: Within 1 weeks after enrollment
Secondary outcomes (1)
Differences in Neuromelanin Volume by group
Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by group
Measured: Within 1 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start2 Nov 2022
- Primary completion2 Jul 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heuron Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phil Hyu Lee, M.D.pH.D, Principal investigator, Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513794
- Sponsor's protocol ID
- qMT-PD-02
- Status last verified
- Jul 2024
- First submitted
- 22 Aug 2022
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Data Collect Study for Development of Neurimelanin Image Analysis System
- ClinicalTrials.gov ID
- NCT05513794
- Acronym / sponsor ID
- qMT-PD-02
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Heuron Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 2 Jul 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Device: MRI ImagingPatient with parkinson disease |
| Healthy volunteer group | Experimental | Device: MRI ImagingHealthy volunteer |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI ImagingNeuromelanin sequence imaging | Device | Healthy volunteer group, Patient group |
Primary outcome
Differences in Neuromelanin Volume by Age
Time frame: Within 1 weeks after enrollment
Descriptive Statistics for Neuromelanin Volume Measured by MRI Image by Age
1 secondary outcome
Differences in Neuromelanin Volume by group
Time frame: Within 1 weeks after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phil Hyu Lee, M.D.pH.D principal investigator
Severance Hospital, Yonsei University Health System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Imaging in people with Parkinson Disease, run by Heuron Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Neuromelanin Volume by Age (time frame: Within 1 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.