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[18F]-FD4 PET imaging of alpha-synuclein in the brain of patients with neurodegenerative diseases

[18F]-FD4 PET imaging of alpha-synuclein in the brain of patients with neurodegenerative diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093084
Enrollment
Unknown
Registered
2024-11-28
Start date
2024-12-09
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

neurodegenerative diseases

Interventions

Gold Standard:Patients with RBD: meet the 2014 International Classification of Sleep Disorders 3 (ICSD-3) diagnostic criteria or the International Classification of Diseases 11 (ICD-11) diagnostic cri
a-syn protein distribution pattern expression value
a-syn protein distribution voxel values

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: Healthy controls: (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. Patients with neurodegenerative diseases: (1) between 45 and 75 years old; No gender limitation. (2) Patients should meet the corresponding diagnostic criteria: RBD diagnostic criteria (meet the 2014 International Classification of Sleep Disorders 3rd Edition (ICSD-3) diagnostic criteria or the International Classification of Diseases 11th edition (ICD-11) diagnostic criteria), PD diagnostic criteria (2021 PD diagnostic guidelines formulated by the International Movement Disorders Society MDS), MSA diagnostic criteria (MSA third edition diagnostic criteria formulated by MDS of the International Movement Disorders Society), PSP diagnostic criteria (2017 MDSPSP diagnostic criteria and 2016 China Progressive supramuclear palsy clinical diagnostic criteria), FTLD diagnostic criteria (2014 frontotemporal lobar degeneration expert consensus), Diagnostic criteria for PDD (2007 edition of the diagnostic guidelines for PDD formulated by the International Movement Disorders Society MDS), diagnostic criteria for DLB (2017 Edition 4 DLB diagnostic criteria), diagnostic criteria for AD (2021 AD clinical diagnostic criteria). The above diagnoses were independently diagnosed by 2 specialists of the corresponding diseases in the Department of Neurology of Huashan Hospital; patients with disputes over the diagnosis were discussed and decided by the movement disorders and cognitive disorders specialized groups of the Department of Neurology of 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 the diagnosis of neurodegenerative diseases, and there was no evidence of other neurological diseases. (4) Informed consent signed in person by the study participant or his/her legal guardian or caregiver. (5) 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. (6) Study participants may be accompanied by a caregiver if necessary. (7) Study participants or their legal representatives understand and sign written informed consent prior to any evaluation. (8) Female study participants must have medical records showing

Exclusion criteria

Exclusion criteria: 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. Patients with neurodegenerative diseases (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

MeasureTime frame
Standard uptake value ratio;

Secondary

MeasureTime frame
a-syn protein distribution pattern expression value;a-syn protein distribution voxel values;sensitivity;specificity;accuracy;

Countries

China

Contacts

Public ContactJian Wang; Fengtao Liu

Huashan Hospital, Fudan University

wangjian_hs@fudan.edu.cn+86 21 5288 9999

Outcome results

None listed

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