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Detection of A-synuclein Aggregate as Biomarker in Diagnosing Parkinson's Disease at Early Stage by Using Protein Misfolding Cyclic Amplification (PMCA)

Detection of A-synuclein Aggregate as Biomarker in Diagnosing Parkinson's Disease at Early Stage by Using Protein Misfolding Cyclic Amplification (PMCA)

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000037856
Enrollment
Unknown
Registered
2020-09-02
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Interventions

Gold Standard:DAT-PET and 18F-FDG PET
Index test:a-synuclein&#32
protein&#32
misfolding&#32
cyclic&#32

Sponsors

Huashan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: For early PD patients Inclusion criteria: 1. Diagnose as 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); 2. Age 50-75, disease duration is less than 1 year, and Hoehn & Yahr Stage I; 3. the dopamine reuptake transporter (DAT) is significantly reduced in striatum on PET imaging; 4. Metabolic brain network detected by fluorine-18-labelled-fluorodeoxyglucose-PET(18F-FDG PET) is consistent with Parkinsons disease-related pattern (PDRP), with FDG hypermetabolism being in basal ganglia and cerebellum; 5. Good response to anti-PD medications; 6. Ability of completing questionnaires; 7. Ability of providing informed consent; 8. Willingness of being assessed by neurologists during off-medication state defined as discontinuing anti-PD medications for at least 12 hours before assessment. For early MSA patients Inclusion criteria: 1. Diagnose as 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); 2. Age 50-75, and disease duration is less than 1 year; 3. Metabolic brain network detected by fluorine-18-labelled-fluorodeoxyglucose-PET(18F-FDG PET) is consistent with MSA related pattern; 4. Ability of completing questionnaires; 5. Ability of providing informed consent; 6. Willingness of being assessed by neurologists during off-medication state defined as discontinuing anti-PD medications for at least 12 hours before assessment. For PSP patients Inclusion criteria: 1. Diagnose as probable PSP by two neurologists specializing in movement disorders according to MDS Clinical Diagnostic Criteria for PSP (2017); 2. Age 50-75, disease duration is less than 1 year; 3. Metabolic brain network detected by fluorine-18-labelled-fluorodeoxyglucose-PET(18F-FDG PET) is consistent with PSP related pattern; 4. Ability of completing questionnaires; 5. Ability of providing informed consent; 6. Willingness of being assessed by neurologists during off-medication state defined as discontinuing anti-PD medications for at least 12 hours before assessment. For controls without diagnosis of neurodegenerative disorders Inclusion criteria: 1. Age 50-75; 2. Precluding with neurodegenerative disease of the central nervous system; 3. Precluding with infective disease of the central system; 4. Ability of completing questionnaires; 5. Ability of providing informed consent.

Exclusion criteria

Exclusion criteria: For early PD patients Exclusion criteria: 1. Secondary parkinsonism (ie. drug induced); 2. Atypical parkinsonisms like MSA or PSP etc; 3. Presence of any item in 10 red flags of the MDS Clinical Diagnostic Criteria for PD (2015) in the comprehensive assessments during follow-up; 4. History of being diagnosed as any cancer within 5 years; 5. Presence of any condition risking the procedure of performing lumbar puncture (LP); 6. Pregnancy; 7. Inability to comply with study procedures. For early MSA patients Exclusion criteria: 1. Secondary parkinsonism (ie. drug induced); 2. History of being diagnosed as any cancer within 5 years; 3. Presence of any condition risking the procedure of performing lumbar puncture (LP); 4. Pregnancy; 5. Inability to comply with study procedures. For PSP patients Exclusion criteria: 1. Secondary parkinsonism (ie. drug induced); 2 History of being diagnosed as any cancer within 5 years; 3. Presence of any condition risking the procedure of performing lumbar puncture (LP); 4. Pregnancy; 5. Inability to comply with study procedures. For controls without diagnosis of neurodegenerative disorders Exclusion criteria: 1. Presents with prodromal symptoms of PD, such as rapid eye movement sleep behavior disorder (RBD); 2. History of being diagnosed as any cancer within 5 years; 3. Presence of any condition risking the procedure of performing lumbar puncture (LP); 4. Pregnancy; 5. Inability to comply with study procedures.

Design outcomes

Primary

MeasureTime frame
The area under curve of the PMCA for the early diagnosis of PD;

Secondary

MeasureTime frame
The sensitivity;The specificity;The positive predictive value;The negative predictive value;The correlation between the PMCA T50 and MDS-UPDRS ? score at baseline in PD patients;The correlation between PMCA T50 and subregional DAT in striatum in PD patients;The correlation between PMCA T50 and PDRP expression value in PD patients;The correlation between PMCA T50 and the change of MDS-UPDRS ? score between the baseline and the follow-up;

Countries

China

Contacts

Public ContactWang Jian

Huashan Hospital Affiliated to Fudan University

wangjian336@hotmail.com+86 13321934789

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026