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Exploratory clinical study of blood-based exosome biomarkers for central nervous system neurodegenerative diseases

Exploratory clinical study of blood-based exosome biomarkers for central nervous system degenerative diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000037983
Enrollment
Unknown
Registered
2020-09-08
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-12-07

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

Conditions

Neurodegenerative diseases of central nervous system

Interventions

Gold Standard:Typical clinical manifestations combined with PET-CT
Index test:Blood exosome test

Sponsors

Huashan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for different disease groups 1. Subjects in cognitive impairment group AD subjects (1) The age is between 40 and 85 years old (including 40 and 85 years old), both male and female; (2) The clinical manifestations were slow progressive deterioration of subjective or objective cognitive function; (3) The severity of ad should be mild to moderate (refer to CDR score of clinical dementia scale less than or equal to 2 points); (4) Neuropsychological assessment (including MMSE, Moca, self rating anxiety scale, geriatric depression scale), brain MRI scan, 18f-av-45 and 18F-FDG-PET examination have been completed in the outpatient or ward of our hospital; (5) The clinical manifestations and auxiliary examination results were consistent with the diagnostic criteria of probable AD proposed by nia-aa joint working group in 2011; (6) The subjects or their legal representatives can understand and sign the informed consent form. DLB subjects (1) The age is between 40 and 85 years old (including 40 and 85 years old), both male and female; (2) The clinical manifestations were progressive fluctuation, cognitive dysfunction with impaired attention and executive ability, visual hallucination and Parkinson's syndrome like manifestations; (3) Neuropsychological assessment (including MMSE, Moca, self rating anxiety scale, geriatric depression scale), brain MRI scan, 11c-cft-pet and 18F-FDG-PET were completed in the outpatient or ward of our hospital; (4) The clinical manifestations and auxiliary examination results were consistent with the most likely DLB diagnostic criteria proposed in the 2017 DLB alliance consensus report; (5) The subjects or their legal representatives can understand and sign the informed consent form. FTD subjects (1) The age is between 40 and 85 years old (including 40 and 85 years old), both male and female; (2) The clinical manifestations were chronic progressive mental and behavioral abnormalities; (3) Neuropsychological assessment (including MMSE, Moca, self rating anxiety scale, geriatric depression scale), brain magnetic resonance imaging (MRI), 11c-cft-pet and 18f-pm-pbb3-pet were completed in the outpatient or ward of our hospital; (4) The clinical manifestations and auxiliary examination results were consistent with the most likely bvftd diagnostic criteria proposed by the international standard alliance for behavioral variant frontotemporal dementia in 2011; (5) The subjects or their legal representatives can understand and sign the informed consent form. 2. Subjects in dyskinesia group PD subjects (1) The age is between 40 and 85 years old (including 40 and 85 years old), both male and female; (2) The clinical manifestations were slow progressive aggravation of unilateral onset limb movement delay with shaking or stiffness; (3) Neuropsychological assessment (including MMSE, Moca, self rating anxiety scale, geriatric depression scale), brain MRI scan, 11c-cft-pet and 18F-FDG-PET were completed in the outpatient or ward of our hospital; (4) The clinical manifestations and auxiliary examination results were in line with the diagnostic criteria of clinically probable PD proposed by the International Association for dyskinesia (MDS) in 2015; (5) The subjects or their legal representatives can understand and sign the informed consent form. MSA subjects (1) The age is between 40 and 85 years old (including 40 and 85 years old), both male and female; (2) The clinical manifestations we

Exclusion criteria

Exclusion criteria: 1. Candidate subjects had MRI and / or PET scan contraindications. Including but not limited to the implantation of metal devices including cardiac pacemaker, intravascular metal device, insulin pump, nerve stimulation device, etc. in patients with uncontrolled hyperglycemia (FBG > 11.1 mmol / L), pregnant women, lactating women or lactating women can not receive repeated intravenous injection, and those who may be allergic to drugs and their components (including those with severe allergy or History of allergic reactions, especially those allergic to the tested drugs), and airtight phobia; 2. Candidate subjects with severe systemic diseases or unstable conditions that make it difficult to complete the agreement project: including but not limited to patients with systemic diseases, including coronary artery disease, heart failure, unstable angina or arrhythmia, uremia, liver failure, sudden stroke, acute myocardial infarction, unstable diabetes mellitus, and having received head injury Intracranial surgery, hypoxia, sepsis or severe infectious diseases, and HIV positive test history; 3. Candidate subjects with neuropsychiatric disorders, including but not limited to encephalitis, epilepsy, schizophrenia, schizophrenic affective disorder or bipolar disorder, which may interfere with neuropsychological assessment results; 4. Candidate subjects who have long-term use of excitatory or inhibitory neuropsychiatric drugs or have a history of alcoholism; 5. The candidate subjects had undergone major surgery in the past 3 months, had significant abnormalities in the laboratory examination, and were clinically considered to have significant or unstable effects, and their life expectancy was less than 1 year. 6. Subjects who are participating in other clinical studies or drug studies.

Design outcomes

Primary

MeasureTime frame
blood exosome;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactCui Mei

Department of Neurology, Huashan Hospital Affiliated to Fudan University

cuimei@fudan.edu.cn+86 15214365396

Outcome results

None listed

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