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Clinical Study of [18F]-FD4 PET Imaging of a-Synuclein in the Brain of Patients with Parkinsonian Disorder

Clinical Study of [18F]-FD4 PET Imaging of a-Synuclein in the Brain of Patients with Parkinsonian Disorder

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093128
Enrollment
Unknown
Registered
2024-11-28
Start date
2024-03-22
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Parkinsonian Disorder

Interventions

Gold Standard:PD: UK PD Association Brain Bank diagnostic criteria MSA: the second Consensus on MSA diagnosis developed in 2008 DLB: established by the third DLB Consortium in 2005

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Healthy Controls: a. Ages between 45 and 70 years; gender is not limited. b. Cognitive function is determined to be normal by the researcher through cognitive testing. CDR score is 0. c. Confirmed by the researcher to have no neurological disease, major chronic disease, malignant tumor, or acute infectious disease, etc. d. No family history of neurological diseases related to movement disorders or cognitive impairment. e. Understand and sign a written informed consent form before any assessment. f. Female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than one year; if they still have the ability to conceive, they must take contraceptive measures to prevent pregnancy within 3 months of the start of the study. g. Male subjects must take contraceptive measures within 3 months of the start of the study. Male subjects are not allowed to donate sperm within 3 months of the start of the study. h. Willing and able to cooperate with all aspects of the study. 2. PD patients: a. Ages between 45 and 70 years; gender is not limited. b. The patients meet the diagnostic criteria for PD (the diagnostic criteria of the UK Parkinson's Disease Association Brain Bank). Confirmed patients need to have at least 3 of the following conditions:? Unilateral onset;? Resting tremor;? Gradual progression of the disease;? Symptoms are asymmetrical, with more severe involvement on the affected side;? Levodopa treatment has obvious therapeutic effects;? Levodopa causes severe dyskinesia;? Levodopa has a therapeutic effect that lasts for 5 years or longer;? The clinical course is 10 years or longer. c. Brain MRI supports the diagnosis of PD, and there is no evidence of other neurological diseases. d. A signed informed consent form by the subject or their legal guardian or caregiver. e. If necessary, the subject may be accompanied by a caregiver. f. Before any assessment, the subject or their legal representative understands and signs a written informed consent form. g. Female subjects must have medical records to prove that they have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than a year; if they still have the ability to conceive, they must take contraceptive measures within 3 months of the start of the study. h. Male subjects must take contraceptive measures within 3 months of the start of the study. Male subjects may not donate sperm within 3 months of the start of the study. i. Willing and able to cooperate with all aspects of the study. 3. MSA patients: a. Between 45 and 70 years old; No gender limitation. b. The patient meets the diagnosis of a probable MSA (the second Consensus on MSA diagnosis developed in 2008). c. Brain MRI supports MSA diagnosis, and there is no evidence of other neurological diseases. d. Informed consent signed in person by the subject or his legal guardian or caregiver. e. Subject may be accompanied by nursing staff if necessary. f. Subject or his legal representative understands and signs a written informed consent prior to any evaluation. g. Female subjects must have medical records showing that they have been surgically sterilized (e.g. hysterectomy, bilateral ovariectomy, or tubal ligation) or have undergone menopause for more than one year; If you are still able to conceive, you should use isolation

Exclusion criteria

Exclusion criteria: 1. Healthy controls: a. Suffering from other serious neurological disorders, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory, immune deficiency, and other serious diseases. b. In the past year, for other clinical medical or scientific research purposes, received ionizing radiation outside the scope of this study, resulting in an annual radiation exposure dose of more than 50 mSv. c. History of drug or alcohol abuse. d. Pregnant or lactating women. e. Poor venous condition, unable to tolerate repeated venipuncture. f. Treatment with an experimental drug or device (whose efficacy or safety is unclear) within 1 month. g. Poor venous condition, unable to tolerate repeated venipuncture. h. Have any conditions in which the author of this study considers any aspect of this test to be harmful or potentially harmful. 2. Patients with PD, MSA and DLB a. Suffering from other serious neurological disorders, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory, immune deficiency, and other serious diseases. b. In the past year, for other clinical medical or scientific research purposes, received ionizing radiation outside the scope of this study, resulting in an annual radiation exposure dose of more than 50 mSv. c. History of drug or alcohol abuse. d. Pregnant or lactating women. e. Poor venous condition, unable to tolerate repeated venipuncture. f. Treatment with an experimental drug or device (whose efficacy or safety is unclear) within 1 month. g. Poor venous condition, unable to tolerate repeated venipuncture. h. Have any conditions in which the author of this study considers any aspect of this test to be harmful or potentially harmful.

Design outcomes

Primary

MeasureTime frame
Standard uptake value ratio;

Secondary

MeasureTime frame
sensitivity;specificity;accuracy;

Countries

China

Contacts

Public ContactYihui Guan

Huashan Hospital, Fudan University, Shanghai, China

guanyihui@hotmail.com+86 21 6428 0718

Outcome results

None listed

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