Skip to content

Clinical exploration of exosomal alpha-syn as a new biomarker in the early diagnosis of alpha-synucleinopathy

Clinical exploration of exosomal alpha-syn as a new biomarker in the early diagnosis of alpha-synucleinopathy

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000037720
Enrollment
Unknown
Registered
2020-08-30
Start date
2020-10-01
Completion date
Unknown
Last updated
2021-07-05

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

Conditions

alpha-synucleinopathy

Interventions

Gold Standard:Clinical diagnosis+PET
based&#32
on&#32

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: PD subjects: 1) Patients that aged between 40-85 years old (including 40 and 85 years old), and there is no restriction on men and women; 2) The clinical manifestations are slow and progressively worsening unilateral onset limbs with slow motion and jitter or stiffness; 3) Neuropsychological assessment (including MMSE, MoCA, Anxiety Self-Rating Scale, Elderly Depression Scale), unenhanced head MRI, 11C-CFT-PET and 18F-FDG-PET examinations have been completed in the outpatient or ward of our hospital 4) The clinical manifestations and auxiliary examination results meet the clinically probable PD diagnostic criteria proposed by the International Movement Disorder Society (MDS) in 2015; 5) The subject or his legal representative can understand and sign the informed consent form. MSA subjects: 1) Patients that aged between 40-85 years old (including 40 and 85 years old), and there is no restriction on men and women; 2) The clinical manifestations are progressively worsening autonomic failure, clinical manifestations like cerebellar ataxia or Parkinson's syndrome like clinical manifestations with levodopa adverse reactions; 3) Neuropsychological assessment (including MMSE, MoCA, Anxiety Self-Rating Scale, Elderly Depression Scale), unenhanced head MRI, 11C-CFT-PET and 18F-FDG-PET examinations have been completed in the outpatient or ward of our hospital 4) The clinical manifestations and auxiliary examination results meet the probable MSA diagnostic criteria proposed in the latest MSA diagnostic consensus published by Neurology in 2008; 5) The subject or his legal representative can understand and sign the informed consent form. PSP subjects: 1) Patients that aged between 40-85 years old (including 40 and 85 years old), and there is no restriction on men and women; 2) The clinical manifestations are progressively worsening postural instability, Parkinson's syndrome-like manifestations and cognitive dysfunction with vertical eye movement disorders; 3) Neuropsychological assessments (including MMSE, MoCA, Anxiety Self-Rating Scale, Elderly Depression Scale), unenhanced head MRI, 11C-CFT-PET and 18F-PM-PBB3- have been completed in the outpatient or ward of our hospital PET inspection; 4) The clinical manifestations and auxiliary examination results meet the probable PSP diagnostic criteria proposed by the 2017 MDS; 5) The subject or his legal representative can understand and sign the informed consent form. DLB subjects 1) Patients that aged between 40-85 years old (including 40 and 85 years old), there is no restriction on men and women; 2) The clinical manifestations are progressive volatility, cognitive dysfunction with impaired attention and execution, with visual hallucinations and Parkinson's syndrome-like manifestations; 3) Neuropsychological assessment (including MMSE, MoCA, Anxiety Self-Rating Scale, Elderly Depression Scale), unenhanced head MRI, 11C-CFT-PET and 18F-FDG-PET examinations have been completed in the outpatient or ward of our hospital 4) The clinical manifestations and auxiliary examination results meet the probable DLB diagnostic criteria proposed in the 2017 DLB Alliance Consensus Report; 5) The subject or his legal representative can understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) The candidate subject has contraindications to MRI and/or PET scanning. Including, but not limited to, candidate subjects implanted with metal devices including cardiac pacemakers, intravascular metal devices, insulin pumps, nerve stimulation devices, etc., and blood glucose levels that have not been effectively controlled (FBG> 11.1mmol/L) ), pregnant, breastfeeding or breastfeeding women, cannot receive repeated intravenous injections, may be allergic to the drug and its components (including a history of severe allergies or allergic reactions, especially those who are allergic to the tested drug), closed phobia. 2) Candidate subjects who have severe systemic diseases or unstable conditions that have difficulty completing the agreed items: including but not limited to those who have systemic diseases including coronary artery disease, heart failure, unstable angina or Arrhythmia, uremia, liver failure, sudden stroke, acute myocardial infarction, unstable diabetes, have had head injury, intracranial surgery, hypoxia, sepsis or severe infectious diseases, human immunodeficiency virus (HIV ) History of positive test; 3) Subjects whose candidates have neuropsychiatric diseases that may interfere with the results of neuropsychological assessment, such diseases include but are not limited to encephalitis, epilepsy, schizophrenia, schizoaffective disorder or bipolar disorder; 4) Alternative subjects who have long-term use of excitatory or inhibitory neuropsychiatric drugs or subjects who have a history of alcohol abuse; 5) The candidate subject has undergone major surgery in the past 3 months, has significant abnormalities in laboratory tests, is clinically considered to have a significant impact or is unstable, and has a life expectancy of less than 1 year. 6) Subjects who are participating in other clinical research or drug research.

Design outcomes

Primary

MeasureTime frame
exosome derived alpha-synuclien;

Countries

China

Contacts

Public ContactMei Cui

Department of Neurology, Huashan Hospital, Fudan University

cuimei@fudan.edu.cn+86 15214365396

Outcome results

None listed

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