Parkinson DiseaseInsIghtPDNCT05631158
Neuromelanin MRI: A Progression Marker in Early PD
An observational study of Parkinson Disease and Progression, Disease, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Prospective observational study to qualify NM-MRI as progression marker in early Parkinson's. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Progression, Disease
- What is being tested?
- MRI
- How many people
- 135 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2020to Jul 2024
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All potential participants need to have to capacity to give consent prior to study enrolment. Study participation is not possible if the participant is unable to give consent or does not have the capacity to consent.
Who may be able to join
- -Inclusion criteria for patients:
- For Parkinson's patients and early-onset Parkinson's:
- Diagnosis of Parkinson's disease, based on UK Brain Bank criteria and made within the preceding 3 years ('recent onset cases'); or
- diagnosed at under 50 years ('under 50 years cases')
- For clinical symptoms suspicious for a diagnosis of PD but clinical uncertainty with regard to a definite diagnosis:
- clinical symptoms not meeting all of the required UK Brain Bank diagnostic criteria for the diagnosis of PD; or
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- clinical features not typically associated with PD and therefore raising the possibility of a different type disorder/movement disorder referred for a DaTSCAN as part of the National Health Service (NHS) clinical diagnostic work-up to investigate a suspicion for a parkinsonian movement disorder-type disease, or referred for a research DaTSCAN as part of existing N3iPD and PaMIR studies for the diagnostic work-up to investigate a suspicion for a parkinsonian movement disorder-type disease.
- Age ≥18 to <90years
- Being able and willing to provide informed consent
- Age ≥18 to <90years
- Being able and willing to provide informed consent
Who cannot join
- The patient has severe comorbid illness that would prevent full study participation
- The patient has features indicating another type of degenerative parkinsonism, e.g. progressive supranuclear palsy
- Drug-induced parkinsonism (Drug-unmasked PD is allowed)
- Symmetrical lower body parkinsonism attributable to significant cortical and/or subcortical cerebrovascular disease (patients with 'incidental' small vessel disease on brain imaging are allowed).
- Negative or normal functional imaging of the presynaptic dopamine system
- The presence of UK Brain Bank exclusion criteria will be recorded at baseline, allowing for the presence of 1 or 2 exclusion criteria (e.g. dopamine antagonist Drug used; more than one affected relative) (if justified e.g. by abnormal SPECT).
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- Any contraindication to Magnetic Resonance (MR) scanning.
- Any major neurological (other than PD), psychiatric or cardiovascular disease or history of brain injury.
- Medical illness or medication that may affect brain morphometry or function.
- Patient who is pregnant and/or breastfeeding.
- Subject has severe comorbid illness that would prevent study participation
- Subject already has a diagnosis of Parkinson's disease
- Any contraindication to Magnetic Resonance (MR) scanning
- Subject who is pregnant and/or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Dorothee Auer, MD PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham
Nottingham
Yue (Lily) Xing, PhD, Yue.Xing@nottingham.ac.uk
About this study
Official title: In Vivo Serial Neuromelanin MRI to Assess Depigmentation Rates in the Substantia Nigra of Early Parkinson's Disease
Prospective observational study to qualify NM-MRI as progression marker in early Parkinson's.
Read the detailed description
Parkinson's is the second most common neurodegenerative disorder with progressive, disabling motor and non- motor symptoms for which effective symptomatic, but non disease-modifying treatment is available. Neuromelanin- containing neurons in the substantia nigra undergo neurodegeneration during Parkinson's disease. There is considerable heterogeneity in the progression of cell loss and clinical symptoms with major research interest in identifying prognostic subtypes.
A non-invasive biomarker that can track the loss of the neuromelanin-containing neurons would be highly desirable to (i) study subtype-specific trajectories of SN depigmentation, (ii) track disease progression in early Parkinson's to assist in stratifying groups and outcome assessment in clinical intervention trials, and (iii) enable patients and their families to better manage their condition including informed forward planning. Neuromelanin MRI (NM-MRI) is a new approach sensitive to the neuromelanin-iron complex, with proven association with the tissue changes of the number of the neuromelanin-containing neurons. Its diagnostic value was established in several studies case-control, but there is a lack of standardisation, multi-centre studies and prospective diagnostic trials. To date only a small, single arm retrospective study reported serial NM loss in Parkinson's.
Building on our previous work, the proposed research entails the development of an early progression biomarker for Parkinson's disease that is pathologically relevant, non-invasive, and uses MRI which is a widely available imaging method for detection. The experimental approach combines advanced computational imaging, retrospective use and extension of existing cohorts with a new dedicated prospective serial study using NM-MRI in uncertain parkinsonism, de novo and early Parkinson and healthy controls using latest MRI technology.
- Conditions
- Parkinson Disease, Progression, Disease
- Being tested
- MRI
- Medical subject headings
- Parkinson Disease, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Also called Blood test, Physical examination
The clinical examination includes a short physical exam, a brief history of allergies, previous diseases and medications, and disease-related questionnaires.
All the participants will undergo 4 serial MRI scans: one MRI scan at the baseline visit, 6, 12, 18 months follow-up visit, respectively to record the changes in the brain, which include the neuromelanin scan.
For future proving the value of our study, we will also collect and store blood samples at the initial visit.
| Study group | Role | What they receive |
|---|---|---|
| Early Parkinson's disease | All the participants will undergo five clinical examination, four MRI scans and one fasting blood test in total in this serial study. Receives: Diagnostic Test: MRI | |
| Healthy Controls | This cohort will undergo the same procedure of the patient's group. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromelanin signal in PD
The primary outcome measure of this study is the neuromelanin-related signal on dedicated 3T MRI.
Measured: 6 months
Secondary outcomes (1)
Depigmentation rates
- differences in depigmentation rates between Parkinson's and controls in extended retrospective cohorts (discovery)
- to assess whether earlier depigmentation rates can predict longer term clinical change based on commonly used outcome markers in clinical trials
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Nov 2020
- Primary completionJun 2024 (estimated)
- Study completionJul 2024 (estimated)
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.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631158
- Sponsor's protocol ID
- 281685
- Acronym
- InsIghtPD
- Status last verified
- Mar 2022
- First submitted
- 18 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A new high-quality neuromelanin MRI database with linked whole brain multimodal MRI, clinical findings and stored blood samples. We intend to quality control and curate the imaging and clinical data for the generation of a data repository, and have included cost for data storage, but ultimately intend to integrate this into the Critical Pathway Initiative. Where possible. We also aim to release imaging-derived parameters to make the data usable for non-imaging communities.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Serial Neuromelanin MRI to Assess Depigmentation Rates in the Substantia Nigra of Early Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05631158
- Acronym / sponsor ID
- InsIghtPD / 281685
- Conditions
- Parkinson Disease, Progression, Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 30 Nov 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.
Prospective observational study to qualify NM-MRI as progression marker in early Parkinson's.
Detailed description
Parkinson's is the second most common neurodegenerative disorder with progressive, disabling motor and non- motor symptoms for which effective symptomatic, but non disease-modifying treatment is available. Neuromelanin- containing neurons in the substantia nigra undergo neurodegeneration during Parkinson's disease. There is considerable heterogeneity in the progression of cell loss and clinical symptoms with major research interest in identifying prognostic subtypes.
A non-invasive biomarker that can track the loss of the neuromelanin-containing neurons would be highly desirable to (i) study subtype-specific trajectories of SN depigmentation, (ii) track disease progression in early Parkinson's to assist in stratifying groups and outcome assessment in clinical intervention trials, and (iii) enable patients and their families to better manage their condition including informed forward planning. Neuromelanin MRI (NM-MRI) is a new approach sensitive to the neuromelanin-iron complex, with proven association with the tissue changes of the number of the neuromelanin-containing neurons. Its diagnostic value was established in several studies case-control, but there is a lack of standardisation, multi-centre studies and prospective diagnostic trials. To date only a small, single arm retrospective study reported serial NM loss in Parkinson's.
Building on our previous work, the proposed research entails the development of an early progression biomarker for Parkinson's disease that is pathologically relevant, non-invasive, and uses MRI which is a widely available imaging method for detection. The experimental approach combines advanced computational imaging, retrospective use and extension of existing cohorts with a new dedicated prospective serial study using NM-MRI in uncertain parkinsonism, de novo and early Parkinson and healthy controls using latest MRI technology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Parkinson's disease | – | Diagnostic Test: MRIAll the participants will undergo five clinical examination, four MRI scans and one fasting blood test in total in this serial study. |
| Healthy Controls | – | Diagnostic Test: MRIThis cohort will undergo the same procedure of the patient's group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All potential participants need to have to capacity to give consent prior to study enrolment. Study participation is not possible if the participant is unable to give consent or does not have the capacity to consent.
Key inclusion criteria (11 listed)
- For Parkinson's patients and early-onset Parkinson's:
- For clinical symptoms suspicious for a diagnosis of PD but clinical uncertainty with regard to a definite diagnosis:
- Age ≥18 to <90years
- Being able and willing to provide informed consent
- Age ≥18 to <90years
Key exclusion criteria (14 listed)
- Subject has severe comorbid illness that would prevent study participation
- Subject already has a diagnosis of Parkinson's disease
- Any contraindication to Magnetic Resonance (MR) scanning
- Subject who is pregnant and/or breastfeeding.
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 |
|---|---|---|
| MRIAlso: Blood test, Physical examinationThe clinical examination includes a short physical exam, a brief history of allergies, previous diseases and medications, and disease-related questionnaires. All the participants will undergo 4 serial MRI scans: one MRI scan at the baseline visit, 6, 12, 18 months follow-up visit, respectively to record the changes in the brain, which include the neuromelanin scan. For future proving the value of our study, we will also collect and store blood samples at the initial visit. | Diagnostic test | Early Parkinson's disease, Healthy Controls |
Primary outcome
Neuromelanin signal in PD
Time frame: 6 months
The primary outcome measure of this study is the neuromelanin-related signal on dedicated 3T MRI.
1 secondary outcome
Depigmentation rates
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: Yes. A new high-quality neuromelanin MRI database with linked whole brain multimodal MRI, clinical findings and stored blood samples. We intend to quality control and curate the imaging and clinical data for the generation of a data repository, and have included cost for data storage, but ultimately intend to integrate this into the Critical Pathway Initiative. Where possible. We also aim to release imaging-derived parameters to make the data usable for non-imaging communities.
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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.
Dorothee Auer, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Progression, Disease, run by University of Nottingham at 1 site in United Kingdom.
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 14 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: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue (Lily) Xing, PhD (44-01158232877, Yue.Xing@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromelanin signal in PD (time frame: 6 months). 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 30 Nov 2022.