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:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT04536857
Eligibility Criteria:
For early PD patients
Inclusion criteria:
* Clinical diagnosis of "probable PD" by two neurologists specializing in movement disorders according to the International Parkinson and Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD (2015);
* Age 50-75, disease duration is less than 1 year, and Hoehn \& Yahr Stage I;
* the dopamine reuptake transporter (DAT) is significantly reduced in striatum on PET imaging;
* Metabolic brain network detected by fluorine-18-labelled-fluorodeoxyglucose-PET(18F-FDG PET) is consistent with Parkinson's disease-related pattern (PDRP), with FDG hypermetabolism being in basal ganglia and cerebellum;
* Good response to anti-PD medications;
* Ability of completing questionnaires;
* Ability of providing informed consent;
* Willingness of being assessed by neurologists during off-medication state defined as discontinuing anti-PD medications for at least 12 hours before assessment.
Exclusion criteria:
* Secondary parkinsonism (ie. drug induced);
* Atypical parkinsonisms like MSA or PSP etc;
* Presence of any item in 10 red flags of the MDS Clinical Diagnostic Criteria for PD (2015) in the comprehensive assessments during follow-up;
* History of being diagnosed as any cancer within 5 years;
* Presence of any condition risking the procedure of performing lumbar puncture (LP);
* Pregnancy;
* Inability to comply with study procedures.
For early MSA patients
Inclusion criteria:
* Clinical diagnosis of "probable MSA" by two neurologists specializing in movement disorders according to the International Parkinson and Movement Disorder Society (MDS) second consensus criteria for MSA (2019);
* Age 50-75, and disease duration is less than 1 year;
* Metabolic brain network detected by fluorine-18-labelled-fluorodeoxyglucose-PET(18F-FDG PET) is consistent with MSA related pattern;
* Ability of completing questionnaires;
* Ability of providing informed consent;
* Willingness of being assessed by neurologists during off-medication state defined as discontinuing anti-PD medications for at least 12 hours before assessment.
Exclusion criteria:
* Secondary parkinsonism (ie. drug induced);
* History of being diagnosed as any cancer within 5 years;
* Presence of any condition risking the procedure of performing lumbar puncture (LP);
* Pregnancy;
* Inability to comply with study procedures.
For PSP patients
Inclusion criteria:
* Clinical diagnosis of "probable PSP" by two neurologists specializing in movement disorders according to MDS Clinical Diagnostic Criteria for PSP (2017);
* Age 50-75, disease duration is less than 1 year;
* Metabolic brain network detected by fluorine-18-labelled-fluorodeoxyglucose-PET(18F-FDG PET) is consistent with PSP related pattern;
* Ability of completing questionnaires;
* Ability of providing informed consent;
* Willingness of being assessed by neurologists during off-medication state defined as discontinuing anti-PD medications for at least 12 hours before assessment.
Exclusion criteria:
* Secondary parkinsonism (ie. drug induced);
* History of being diagnosed as any cancer within 5 years;
* Presence of any condition risking the procedure of performing lumbar puncture (LP);
* Pregnancy;
* Inability to comply with study procedures.
For controls without diagnosis of neurodegenerative disorders
Inclusion criteria:
* Age 50-75;
* No history of neurodegenerative disease of the central nervous system;
* No history of infective disease of the central system;
* Ability of completing questionnaires;
* Ability of providing informed consent.
Exclusion criteria:
* With prodromal symptoms of PD, such as rapid eye movement sleep behavior disorder (RBD);
* History of being diagnosed as any cancer within 5 years;
* Presence of any condition increasing the risk of the procedure of performing lumbar puncture (LP);
* Pregnancy;
* Inability to comply with study procedures.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT04536857
Study Brief:
Protocol Section:
NCT04536857