Neuromelanin MRI: A Progression Marker in Early PD

NCT05631158 | Unknown

• 1 other identifier: 281685
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective observational study to qualify NM-MRI as progression marker in early Parkinson's.

Conditions

Parkinson Disease; Progression, Disease

Outcome Measures

Primary Outcomes (1)

• Neuromelanin signal in PD

  The primary outcome measure of this study is the neuromelanin-related signal on dedicated 3T MRI.

  6 months

Secondary Outcomes (1)

• Depigmentation rates

  2 years

Study Arms (2)

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.

Diagnostic Test: MRI

Healthy Controls

This cohort will undergo the same procedure of the patient's group.

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

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.

Also known as: Blood test, Physical examination

Early Parkinson's disease; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Disease Progression

Interventions

Hematologic Tests; Physical Examination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Yue (Lily) Xing, PhD

CONTACT

44-01158232877; Yue.Xing@nottingham.ac.uk

Dorothee Auer, MD PhD

CONTACT

Dorothee.Auer@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 30, 2022
• Study Start: November 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 30, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: within 5 years
• Access Criteria: Open access

Locations

GB (1)