Parkinson's disease and multiple system atrophy
Conditions
Interventions
PD Group:Inject the [18F]-FD4 tracer
MSA Group:Inject the [18F]-FD4 tracer
HC Group:Inject the [18F]-FD4 tracer
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Inclusion criteria: Clinical trial study participants must meet all of the following criteria: 1.1 Healthy volunteers: (1) between 45 and 75 years old; No gender limitation. (2) The cognitive function was found to be normal by the researchers through cognitive tests. The UPDRS III score is 0. (3) No neurological diseases, major chronic diseases, malignant tumors or acute infectious diseases have been confirmed by researchers. (4) No family history of neurological diseases related to movement disorders and cognitive disorders. (5) Understand and sign written informed consent prior to any assessment. (6) Female study participants must have medical records showing that they have been surgically sterilized (such as hysterectomy, bilateral ovariectomy, or tubal ligation) or have been menopausal for more than one year; If you are still able to conceive, you should use isolation contraception within 3 months after the start of the study. (7) Male study participants were required to use isolation contraception within 3 months of the start of the study. Male study participants were not allowed to donate sperm for 3 months after the start of the study. (8) Willing and able to cooperate with all projects of this study. 1.2 PD patients: (1) between 45 and 75 years old; No gender limitation. (2) Patients should meet the diagnostic criteria for PD (2015 PD Diagnostic Guidelines formulated by MDS of the International Movement Disorders Society) 4. The diagnosis was made independently by 2 specialists in the Department of Neurology of Huashan Hospital. Patients whose diagnosis is disputed shall be discussed and decided by the movement disorder special team of the Department of Neurology, Huashan Hospital. However, the necessary a-syn related pathological examination recommended by the diagnostic criteria should be carried out in the subsequent research process, and the necessary diagnosis confirmation or diagnosis change should be carried out. (3) Brain MRI supported PD diagnosis, and there was no evidence of other neurological diseases. (4) Drugs used to improve the clinical symptoms of neurodegenerative movement disorders must be maintained at a steady dose for more than 30 days before starting the study. (5) Study participants may be accompanied by caregivers if necessary. (6) Study participants or their legal representatives understand and sign written informed consent prior to any evaluation. (7) Female study participants must have medical records showing that they have been surgically sterilized (such as hysterectomy, bilateral ovariectomy, or tubal ligation) or have been menopausal for more than one year; If you are still able to conceive, you should use isolation contraception within 3 months after the start of the study. (8) Male study participants were required to use isolation contraception within 3 months of the start of the study. Male study participants were not allowed to donate sperm for 3 months after the start of the study. (9) Willing and able to cooperate with all projects of this study.1.3 MSA patients: (1) between 45 and 75 years old; No gender limitation. (2) MSA diagnostic criteria for patients (the third edition of MSA diagnostic criteria formulated by MDS of the International Movement Disorders Society) 5. The diagnosis was made independently by 2 specialists in the Department of Neurology of Huashan Hospital. Patients whose diagnosis is disputed shall be discussed and decided by the movement disorder special team of the Dep
Exclusion criteria
Exclusion criteria: 2 Exclusion criteria: Study participants who meet any of the following criteria will be excluded from the study: 2.1 Healthy controls: (1) Patients with neurodegenerative diseases, or suffering from serious other neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory, immune deficiency and other serious diseases. (2) have received ionizing radiation outside the scope of this study in the past year for other clinical medical or scientific research purposes, resulting in an annual radiation exposure of more than 50 mSv. (3) A history of drug or alcohol abuse. (4) Pregnant or lactating women. (5) Poor venous conditions, unable to tolerate repeated venipuncture. (6) have received experimental drug or device treatment (efficacy or safety is unclear) within 1 month. (7) There is any condition in which the author of this study believes that any link related to this test may cause harm or potentially harm. 2.2 PD patients (1) suffering from other serious diseases of the nervous system, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory system, immune deficiency and other serious diseases. (2) have received ionizing radiation outside the scope of this study in the past year for other clinical medical or scientific research purposes, resulting in an annual radiation exposure of more than 50 mSv. (3) A history of drug or alcohol abuse. (4) Pregnant or lactating women. (5) Poor venous conditions, unable to tolerate repeated venipuncture. (6) have received experimental drug or device treatment (efficacy or safety is unclear) within 1 month. (7) Poor venous conditions, unable to tolerate repeated venipuncture. (8) There is any condition in which the author of this study believes that any link related to this test may cause harm or potentially harm. 2.3 MSA patients (1) suffering from other serious diseases of the nervous system, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory system, immune deficiency and other serious diseases. (2) have received ionizing radiation outside the scope of this study in the past year for other clinical medical or scientific research purposes, resulting in an annual radiation exposure of more than 50 mSv. (3) A history of drug or alcohol abuse. (4) Pregnant or lactating women. (5) Poor venous conditions, unable to tolerate repeated venipuncture. (6) have received experimental drug or device treatment (efficacy or safety is unclear) within 1 month. (7) Poor venous conditions, unable to tolerate repeated venipuncture. (8) There is any condition in which the author of this study believes that any link related to this test may cause harm or potentially harm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standard uptake value ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| a-syn protein distribution pattern expression value;a-syn protein distribution voxel values;sensitivity;specificity;accuracy; | — |
Countries
China
Contacts
Public ContactJian Wang
Department of Neurology, Huashan Hospital Affiliated to Fudan University
Outcome results
None listed