【ChiCTR2000037856】王坚医师：注册表内容须中、英文双语填写，请补充中文内容。 Detection of A-synuclein Aggregate as Biomarker in Diagnosing Parkinson's Disease at Early Stage by Using Protein Misfolding Cyclic Amplification (PMCA)

ChiCTR2000037856

正在进行

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2020-09-02

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帕金森病

王坚医师：注册表内容须中、英文双语填写，请补充中文内容。 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)

The study will investigate the biomarker of a-synuclein aggregate in CSF detected by protein misfolding cyclic amplification (PMCA) and its sensitivity and specificity in diagnosing Parkinson's disease at H-Y stage I and disease duration less than 1 year, compared with that from agematched controls without neurodegeneration, those with Multiple System Atrophy (MSA) as a disease control with a-synucleinopathy, and those with Progressive Supranuclear Palsy (PSP) as a control with non-a-synucleinopathy neurodegeneration.

析因分组（即根据危险因素或暴露因素分组）

探索性研究/预试验

不适用

未说明

上海申康医院发展中心

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2020-10-01

2022-09-30

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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.；

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.；

复旦大学附属华山医院

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