Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT05631158
Eligibility Criteria:
Inclusion Criteria:
-Inclusion criteria for patients:
* For Parkinson's patients and early-onset Parkinson's:
1. Diagnosis of Parkinson's disease, based on UK Brain Bank criteria and made within the preceding 3 years ('recent onset cases'); or
2. 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:
1. clinical symptoms not meeting all of the required UK Brain Bank diagnostic criteria for the diagnosis of PD; or
2. 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
Inclusion criteria for healthy controls:
* Age ≥18 to \<90years
* Being able and willing to provide informed consent
Exclusion Criteria:
* Exclusion criteria for patients:
1. The patient has severe comorbid illness that would prevent full study participation
2. The patient has features indicating another type of degenerative parkinsonism, e.g. progressive supranuclear palsy
3. Drug-induced parkinsonism (Drug-unmasked PD is allowed)
4. Symmetrical lower body parkinsonism attributable to significant cortical and/or subcortical cerebrovascular disease (patients with 'incidental' small vessel disease on brain imaging are allowed).
5. Negative or normal functional imaging of the presynaptic dopamine system
6. 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).
7. Any contraindication to Magnetic Resonance (MR) scanning.
8. Any major neurological (other than PD), psychiatric or cardiovascular disease or history of brain injury.
9. Medical illness or medication that may affect brain morphometry or function.
10. Patient who is pregnant and/or breastfeeding.
Exclusion criteria for healthy controls:
1. Subject has severe comorbid illness that would prevent study participation
2. Subject already has a diagnosis of Parkinson's disease
3. Any contraindication to Magnetic Resonance (MR) scanning
4. Subject who is pregnant and/or breastfeeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05631158
Study Brief:
Protocol Section:
NCT05631158