Last updated: November 18, 2022
Sponsor: University of Nottingham
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT05631158
281685
Ages 18-90 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 withinthe 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 withregard to a definite diagnosis:
- clinical symptoms not meeting all of the required UK Brain Bank diagnosticcriteria for the diagnosis of PD; or
- clinical features not typically associated with PD and therefore raising thepossibility of a different type disorder/movement disorder referred for a DaTSCANas part of the National Health Service (NHS) clinical diagnostic work-up toinvestigate a suspicion for a parkinsonian movement disorder-type disease, orreferred for a research DaTSCAN as part of existing N3iPD and PaMIR studies forthe diagnostic work-up to investigate a suspicion for a parkinsonian movementdisorder-type disease.
- Age ≥18 to <90years
- Being able and willing to provide informed consent Inclusion criteria for healthy controls:
- Age ≥18 to <90years
- Being able and willing to provide informed consent
Exclusion
Exclusion Criteria:
- Exclusion criteria for patients:
- The patient has severe comorbid illness that would prevent full studyparticipation
- 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/orsubcortical cerebrovascular disease (patients with 'incidental' small vesseldisease 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 antagonistDrug used; more than one affected relative) (if justified e.g. by abnormalSPECT).
- Any contraindication to Magnetic Resonance (MR) scanning.
- Any major neurological (other than PD), psychiatric or cardiovascular disease orhistory 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 participation
- Subject already has a diagnosis of Parkinson's disease
- Any contraindication to Magnetic Resonance (MR) scanning
- Subject who is pregnant and/or breastfeeding.
Study Design
Total Participants: 135
Study Start date:
November 01, 2020
Estimated Completion Date:
July 31, 2024
Study Description
Connect with a study center
University of Nottingham
Nottingham,
United KingdomActive - Recruiting
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