TDP-43-related neurodegenerative diseases (such as ALS, FTLD)
Conditions
Interventions
Gold Standard:ALS diagnostic criteria (EI Escorial diagnostic criteria) or FTLD diagnostic criteria (International Expert Consensus on Behavioral Variant Frontotemporal Dementia)
Index test:[18F]-BJF-03 PET
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: Healthy controls: (1) Age between 30 and 70 years; gender not limited. (2) Cognitive function was assessed as normal by the investigator through cognitive testing. A score of 0 on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and the Unified Parkinson's Disease Rating Scale Part III (UPDRS III) was required. (3) No neurological disorders, major chronic diseases, malignant tumors, or acute infectious diseases were confirmed by the investigator. (4) Brain MRI showed no evidence of other neurological diseases. (5) Written informed consent was obtained before any evaluation was conducted. (6) Female participants must have medical records proving they have undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than one year; if still capable of conception, they must use abstinence contraception for 3 months after the start of this study. (7) Male participants must use abstinence contraception for 3 months after the start of this study. Male participants are not allowed to donate sperm within 3 months of the start of this study. (8) Willing and able to cooperate with all aspects of this study. Patients with neurodegenerative diseases: (1) Age between 30 and 70 years; gender not limited. (2) Patients should meet the corresponding diagnostic criteria: ALS diagnostic criteria (EI Escorial criteria) or FTLD diagnostic criteria (International Consensus on Behavioral Variant Frontotemporal Dementia). All diagnoses are made independently by two specialists in the corresponding diseases at the Department of Neurology, Huashan Hospital; for patients with disputed diagnoses, the decision is made by the Motor Disorders Group and the Cognitive Disorders Group of the Department of Neurology, Huashan Hospital. (3) Brain MRI supports the diagnosis of neurodegenerative disease, and TAU PET scans of subjects in the FTLD group show no evidence of other neurological diseases. (4) Informed consent must be provided in writing by the study participant or their legal guardian/caregiver. (5) Medications used to improve clinical symptoms of neurodegenerative movement disorders must be maintained at a stable dose for at least 30 days before initiating this study. (6) If necessary, study participants may be accompanied by a caregiver. (7) Before any assessment, the study participant or their legal representative must understand and sign a written informed consent form. (8) Female study participants must have medical records proving they have undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for more than one year; if still capable of conceiving, they must use abstinence contraception for 3 months after the start of this study. (9) Male study participants must use abstinence contraception for 3 months after the start of this study. Male study participants may not donate sperm for 3 months after the start of this study. (10) Willing and able to cooperate with all projects of this study.
Exclusion criteria
Exclusion criteria: Healthy controls: (1) Patients with neurodegenerative diseases, or other serious neurological disorders, or gastrointestinal, cardiovascular, liver, kidney, hematologic, tumor, endocrine, respiratory, immunodeficiency, or other serious diseases. (2) Within the past year, received ionizing radiation outside the scope of this study for other clinical or scientific research purposes, resulting in an annual radiation exposure dose exceeding 50 mSv. (3) History of drug abuse or alcoholism. (4) Pregnant or lactating women. (5) Poor venous access, unable to tolerate repeated venipuncture. (6) Received treatment with an experimental drug or device (of uncertain efficacy or safety) within the past month. (7) Any condition that the study administrator believes may cause harm or has potential harm in any aspect of this study. Patients with neurodegenerative diseases: (1) Patients with other serious neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, hematologic, tumor, endocrine, respiratory, immunodeficiency, or other serious diseases. (2) Within the past year, the individual has received ionizing radiation outside the scope of this study for other clinical medical or scientific research purposes, resulting in an annual radiation exposure dose exceeding 50 mSv. (3) History of drug abuse or alcoholism. (4) Pregnant or lactating woman. (5) Poor venous access, unable to tolerate repeated venipuncture. (6) Received treatment with an experimental drug or device (of uncertain efficacy or safety) within the past month. (7) Poor venous access, unable to tolerate repeated venipuncture. (8) Any condition that the study administrator believes may cause harm or has potential harm in any aspect of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TDP-43 standard uptake value ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| TDP-43 distribution pattern based on voxel level; | — |
Countries
China
Contacts
Public ContactYihui Guan; Chuantao zuo
Huashan Hospital, Fudan University
Outcome results
None listed