Parkinson's Disease and Related Disorders
Conditions
Interventions
Advanced PD:None
RBD:None
Early PD:None
Healthy Control:None
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Controls: (1) Aged between 45 and 75 years, of either sex; (2) Deemed to have normal cognitive function by the investigator based on cognitive assessments, with a UPDRS Part III score of 0; (3) Confirmed by the investigator to have no neurological disorders, major chronic diseases, malignant tumors, or acute infectious diseases, etc.; (4) No family history of neurological disorders related to movement disorders or cognitive impairment; (5) Willing and able to understand and sign the written informed consent form prior to the initiation of any assessments; (6) Female participants must have medical documentation confirming surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) or postmenopausal status for more than one year; if of childbearing potential, they must agree to use barrier contraceptive measures for 3 months after the start of the study; (7) Male participants must agree to use barrier contraceptive measures for 3 months after the start of the study and must refrain from sperm donation during this period. 2.Inclusion criteria for PD patients: Age between 40 and 75 years (inclusive), with a male-to-female ratio of approximately 1:1 at enrollment; diagnosis of PD conforms to the UK Parkinson's Disease Society Brain Bank diagnostic criteria, and confirmed patients must meet 3 or more of the following conditions: (1) unilateral onset; (2) resting tremor; (3) gradual disease progression; (4) asymmetric symptoms with more severe involvement on the side of onset; (5) significant therapeutic response to levodopa; (6) levodopa-induced severe dyskinesia; (7) levodopa efficacy lasting 5 years or longer; (8) clinical course of 10 years or longer; participants themselves and their legally authorized representatives are able to understand and sign the informed consent form. 3.Inclusion criteria for the prodromal stage of PD (i.e., patients with REM sleep behavior disorder): Age between 40 and 75 years (inclusive). All enrolled RBD patients must be confirmed by polysomnography (PSG) to meet the diagnostic criteria for REM sleep without atonia, and meet at least one of the following criteria: (1) a history of injurious or potentially injuring motor behaviors; (2) complex motor behaviors during REM sleep documented by simultaneous PSG video recording. All patients must undergo a comprehensive evaluation by a neurologist at enrollment to ensure that there is no evidence of PD, other overlapping syndromes, or dementia. Other forms of sleep disorders may be excluded based on medical history and PSG findings. Participants themselves and their legally authorized representatives are able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of atypical Parkinson's disease symptoms or various causes that may lead to secondary Parkinson's syndrome; 2. Participants have contraindications for MRI and/or PET scans, including but not limited to implanted metal devices (such as pacemakers, vascular metal implants, insulin pumps, neurostimulators, etc.), uncontrolled blood sugar, pregnancy or breastfeeding, inability to tolerate repeated intravenous injections, allergies to drugs or their components (including severe allergies or history of allergic reactions, especially to the study drug), or claustrophobia; 3. Currently participating in other clinical studies, or in the past year, aside from the expected radiation exposure of this study, have participated in other study protocols or clinical care that resulted in cumulative radiation exposure exceeding 50 mSv effective dose; 4. Presence of the following hard-to-control clinical conditions, including but not limited to systemic diseases (like coronary artery disease, heart failure, unstable angina or arrhythmias, uremia, liver failure, sudden stroke, acute myocardial infarction, unstable diabetes), history of head injury or intracranial surgery, hypoxia, sepsis or severe infectious diseases, mental disorders, epilepsy and severe depression (or history of), positive HIV test history; 5. Major surgery within the past 3 months, or significant abnormalities in lab tests judged clinically significant or unstable, with an expected lifespan of less than 1 year; 6. History of drug abuse or heavy alcohol use for at least 3 months; 7. Any clinical condition that the researcher believes may cause or potentially cause harm with the use of this drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Semi-quantitative measurement of a-synuclein deposition based on 18 F-FD4 PET (SUVR);Severity of motor symptoms (assessed by the motor examination section of the Unified Parkinson's Disease Rating Scale, UPDRS Part III);Semi quantitative measurement of dopaminergic system function based on DAT PET (SUVR);Semi quantitative assessment of fiber tract supervised subcortical metabolic network (FSMN) metrics derived from 18F-FDG PET imaging; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function assessment (assessment tools: PDQ 39, AVLT, Boston Naming Test, Verbal Fluency Test, SDMT, Trail Making Test Part A, Trail Making Test Part B, and Stroop Color Word Test);Adverse events; | — |
Countries
China
Contacts
Public ContactGe Jingjie
Huashan Hospital, Fudan University
Outcome results
None listed