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Exploration of Plasma Neuron-Derived Exosomal a-Synuclein in the Diagnosis of Parkinson's Disease

Exploration of Plasma Neuron-Derived Exosomal a-Synuclein in the Diagnosis of Parkinson's Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127698
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Parkinson’s disease

Interventions

Gold Standard:The foremost diagnostic criterion is to establish definite parkinsonism, defined as the presence of bradykinesia plus at least one of the other two cardinal features—rest tremor or rigid
>= 2 supportive criteria
no red flags. Probable PD: no absolute exclusions
red flags must be offset by supportive criteria – 1 red flag needs >=1 support
2 flags need >=2 support
>2 flags exclude diagnosis.
Index test:Plasma neuron-derived exosomes were isolated and their a-synuclein content was quantified by magnetic-particle chemiluminescence immunoassay.

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Aged 45 to 80 years, regardless of gender. 2.Diagnosed with Parkinson’s disease (PD) according to the 2015 Movement Disorder Society (MDS) diagnostic criteria. 3.Ability to understand the study procedures, willingness to participate, and provision of a signed informed consent form. 4.Age- and sex-matched healthy subjects.

Exclusion criteria

Exclusion criteria: 1.Patients with other neurological diseases such as cerebrovascular disease, hydrocephalus, brain tumors, or traumatic brain injury. 2.Patients with severe heart disease, organic damage to the liver, kidneys, or other organs, or severe hepatic or renal insufficiency. 3.Patients with severe cognitive impairment, major psychiatric disorders (e.g., schizophrenia), or severe psychological disorders that prevent cooperation with the examinations. 4.Any other circumstances that, in the investigator's judgment, make the patient unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Area Under the Curve;Specificity;Youden’s index;

Countries

China

Contacts

Public ContactSu Wen

Beijing Hospital

suwendy@126.com+86 10 85133227

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026