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NCT05631158
Neuromelanin MRI: A Progression Marker in Early PD
Conditions: Parkinson Disease, Progression, Disease
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: 1
Enrollment: 135
Sponsor: University of Nottingham
Location: United Kingdom
Summary
Prospective observational study to qualify NM-MRI as progression marker in early Parkinson's.
Eligibility Criteria
Inclusion Criteria:-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'); ordiagnosed 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; orclinical 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 <90yearsBeing able and willing to provide informed consentInclusion criteria for healthy controls:Age ≥18 to <90yearsBeing able and willing to provide informed consentExclusion Criteria:Exclusion criteria for patients:The patient has severe comorbid illness that would prevent full study participationThe patient has features indicating another type of degenerative parkinsonism, e.g.
progressive supranuclear palsyDrug-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 systemThe 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).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.Exclusion criteria for healthy controls:Subject has severe comorbid illness that would prevent study participationSubject already has a diagnosis of Parkinson's diseaseAny contraindication to Magnetic Resonance (MR) scanningSubject who is pregnant and/or breastfeeding.
Source: ClinicalTrials.gov (NCT05631158). StuddyBuddy aggregates publicly available trial information.