Blood test measuring alpha‑synuclein clumping to detect neurodegenerative conditions

Plasma a-Synuclein Aggregation Seeding Activity as a Novel Biomarker for Neurodegeneration Disease

This project will test whether a blood test that detects alpha‑synuclein clumping can help identify Parkinson's disease, MSA, PSP and related synucleinopathies.

Quick facts

• Study type: Observational
• Enrollment: 458 (estimated)
• Ages: 18 Years to 95 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (other)
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07498686 on ClinicalTrials.gov

What this trial studies

This is an observational project based at Xuanwu Hospital that measures alpha‑synuclein aggregation seeding activity in plasma using RT‑QuIC–style assays. Researchers will enroll patients diagnosed or likely to have Parkinson's disease and related synucleinopathies under the 2015 MDS diagnostic criteria and collect clinical information alongside blood samples. The goal is to compare plasma seeding activity patterns across clinical groups to find signals that distinguish different synucleinopathies. The work aims to build a clinical database and correlate blood assay results with clinical features to develop a less invasive diagnostic biomarker.

Who should consider this trial

Good fit: Ideal candidates are people with a clinical or probable diagnosis of Parkinson's disease or related synucleinopathies who attend the outpatient clinics at Xuanwu Hospital and can give informed consent.

Not a fit: People whose symptoms are caused by non‑synuclein pathologies (for example primary Alzheimer disease or vascular causes) are unlikely to benefit from this specific alpha‑synuclein blood assay.

Why it matters

Potential benefit: If successful, this could provide a less invasive blood biomarker to diagnose synucleinopathies earlier and more accurately.

How similar studies have performed: CSF RT‑QuIC and related seeding assays have shown promising diagnostic accuracy in prior research, but plasma-based aggregation assays are newer and less extensively validated.

Eligibility criteria

Inclusion Criteria:

\- Grouping criteria for PD patients: All PD patients who join the group need to meet the following conditions at the same time: The diagnosis of primary PD patients is based on the 2015 International Association for Movement Disorders (MDS) Parkinson's disease diagnosis standard, and all patients need to meet the clinical diagnosis or likely Parkinson's disease diagnosis criteria. Quasi; All patients come from the outpatient clinic of Xuanwu Hospital Affiliated to Capital Medical University, and the clinical evaluation and disease diagnosis are completed by a movement disorder specialist. This project is approved by the Ethics Committee of Xuanwu Hospital Affiliated to Capital Medical University. The subjects who participated in the study signed the informed consent form. Fully improve the information of PD patients and form an NSFC 2024 clinical information database. Establish an evaluation scale based on various indicators such as basic demographic data, general disease status and past history and exercise symptom evaluation, including Hoehn \& Yahr staging, unified Parkinson's disease assessment scale (MDS- UPDRS), concise mental state examination (MMSE) examination, Monte Lear scale (MOCA), rapid eye movement sleep behavior disorder Hong Kong questionnaire (RBDQ-HK), Hamilton depression scale (HAMD) and anxiety scale (HAMA), integrating a number of sports and non-sports indicators, comprehensively considering and evaluating the patient's condition, for the follow-up relevant Sexual analysis provides accurate and complete clinical information.MSA patients need to meet the MSA clinical diagnosis criteria updated in 2008 by the Europe Multiple System Atrophy Study Group (EMSA-SG). For DLB patients, use the 2017 standard for diagnosis and grouping.

Exclusion Criteria:

* Patients with Parkinson's syndrome but not primary PD, patients with brain surgery/deep brain electrode stimulation, or patients diagnosed with dementia according to the Diagnostic and Statistical Manual of Mental Illness formulated by the American Association of Mental Illness. PD patients with mild cognitive dysfunction are not excluded.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Xuanwu Hospital — Beijing, Beijing Municipality, China (COMPLETED)
• Xuanwu Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Weiwei YANG, Ph.D.

Conditions: RT-QuIC, PD, MSA, PSP, Neurodegeneration disease, alpha-synuclein