Integrated Digital and Neurogenic Exosome Biomarkers for Early Diagnosis of Parkinson's Disease: Development and Application
25 de junio de 2026 actualizado por: Fujian Medical University Union Hospital
Based on the high-quality Parkinson's disease cohort population and biological sample database in the early stage of the team, multi-dimensional intelligent wearable device technology and machine learning were used to screen and classify digital biomarkers in the prodromal PD cohort, early PD cohort and healthy population cohort.
Using peptide nanoprobes, metabolomics and Simoa technology to find the pathological molecular biomarkers of high-purity blood neurogenic exosomes in the prodromal stage of PD cohort, early PD cohort and healthy population cohort, and conduct classification and combination study.
The association analysis was used to explore the specific internal relationship between digital biomarkers and neurogenic exosome molecular biomarkers, to explore the potential relationship between the two types of biomarkers, and to further apply machine learning methods to establish a fusion model for early diagnosis of PD including markers related to digital phenotype and pathological molecular mechanism, and to verify it clinically.
The research results of this project are expected to bring new strategies for the early diagnosis of PD biomarkers, provide theoretical support for clinical transformation, and have important clinical significance for achieving the goal of early diagnosis and early treatment.
Descripción general del estudio
Estado
Estado
Reclutamiento
Condiciones
Condiciones
Tipo de estudio
Tipo de estudio
De observación
Inscripción (Estimado)
Inscripción
700
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: qinyong ye
- Número de teléfono: 13365910205
- Correo electrónico: unionqyye@163.com
Ubicaciones de estudio
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Fujian
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Fuzhou, Fujian, Porcelana, 350000
- Reclutamiento
- Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union Hospital
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Contacto:
- Department of Neurology, Fujian Institute of Geriatrics, Fujia Department of Neurology, Fujian Institute of Geriatrics, Fujia
- Número de teléfono: +86 591 8621 8329
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra de probabilidad
Población de estudio
This study comprises a combined retrospective and prospective cohort of patients with idiopathic Parkinson's disease (PD), selected from the PD registry database maintained by our team at Fujian Medical University Union Hospital.
The study population includes individuals who meet all of the following criteria: (1) diagnosed with idiopathic PD based on the Movement Disorder Society (MDS) clinical diagnostic criteria; (2) Hoehn-Yahr (H-Y) stage ≤ 2.0 during off-medication periods; and (3) Mini-Mental State Examination (MMSE) score > 24 points.
Eligible participants will be identified from the existing database for retrospective data collection, while prospective follow-up data will be collected for the same cohort to enable comprehensive longitudinal analyses.
Descripción
Inclusion Criteria:
1. Healthy Control Group
- No severe mental illness;
- Mini-Mental State Examination (MMSE) score >24 points; 2. Prodromal PD Group
- Meets the diagnostic criteria for rapid eye movement sleep behavior disorder;
- Has no severe mental disorders;
- Mini-Mental State Examination (MMSE) score is greater than 24 points. 3. Early PD Group
(1) Diagnosed with idiopathic Parkinson's disease based on the MDS clinical diagnostic criteria ; (3) Hoehn-Yahr (H-Y) stage <=2.0 during off-medication periods; (4) Mini-Mental State Examination (MMSE) score >24 points;
Exclusion Criteria:
- Presence of mental, cognitive, or psychological disorders, unable to sign informed consent;
- Presence of other diseases affecting walking distance, such as lower limb joint lesions, spinal lesions, neurological disorders, or severe cardiopulmonary diseases;
- Presence of intracranial structural changes, cerebrovascular disease, or other neurological disorders;
- Presence of tumors, severe liver or kidney dysfunction (indicators exceeding three times the normal value), or other conditions that significantly impact health;
- Claustrophobia or presence of implants affecting MRI scanning.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
3
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
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Control de salud
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PD prodromal group
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Early PD group
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mini-mental State Examination
Periodo de tiempo: baseline
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Mini-Mental State Examination (MMSE) is a 30-item cognitive screening tool assessing orientation, memory, attention, calculation, and language, with total scores ranging from 0 to 30.
Higher scores indicate better cognitive function.
Scores ≥27 generally indicate normal cognition, while lower scores suggest varying degrees of impairment, with cutoffs adjusted for education and age.
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baseline
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Montreal Cognitive Assessment
Periodo de tiempo: baseline
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Montreal Cognitive Assessment (MoCA) is a 10-15 minute screening tool covering 8 cognitive domains through 12 tasks, with total scores ranging from 0 to 30.
Higher scores indicate better cognitive function.
Scores ≥26 are generally considered normal, with a 1-point adjustment for education ≤12 years; scores <26 suggest possible cognitive impairment.
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baseline
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The 39-Item Parkinson's Disease Questionnaire
Periodo de tiempo: baseline
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Non-Motor Symptoms Scale (NMSS) assesses frequency and severity of non-motor symptoms across all stages of Parkinson's disease, covering autonomic, affective, cognitive, sleep, and other domains.
Total scores range from 0 to 360.
Higher scores indicate worse outcome (greater symptom burden).
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baseline
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Hamilton Depression Rating Scale
Periodo de tiempo: baseline
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Hamilton Depression Rating Scale (HAM-D) is a clinician-rated instrument assessing depression severity across multiple dimensions including mood, somatic symptoms, anxiety, and sleep disturbance.
The 17-item version (HAM-D17) yields total scores ranging from 0 to 52.
Higher scores indicate worse outcome (greater depressive symptom severity), with scores ≥23 indicating very severe depression.
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baseline
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hoehn-yahr stage
Periodo de tiempo: baseline
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Hoehn and Yahr Scale (HY) is a clinician-rated instrument assessing clinical severity and disease staging in Parkinson's disease.
Staging ranges from 0 (no symptoms) to 5 (severe disability requiring full dependence).
Higher stages indicate worse outcome (more advanced disease with greater functional impairment), primarily based on postural instability and disability.
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baseline
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Movement Disorder Society-Sponsored Revision Of The Unified Parkinson's Disease Rating Scale
Periodo de tiempo: baseline
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Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive instrument assessing Parkinson's disease across four parts: non-motor symptoms, activities of daily living, motor symptoms, and complications.
Total scores range from 0 to 260 (Part I: 0-52, Part II: 0-52, Part III: 0-132, Part IV: 0-24).
Higher scores indicate worse outcome (greater impairment).
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baseline
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Wearable devices measure gait parameters
Periodo de tiempo: baseline
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Wearable Device System (GYENNO MATRIX) is a 10-sensor system sampling at 100 Hz to capture 3D angular velocity, acceleration, and geomagnetic field data.
It extracts gait parameters (step length, stride, gait cycle) and detects postural transitions (standing, sitting, turning).
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baseline
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Sniffin' Sticks 12
Periodo de tiempo: baseline
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Sniffin' Sticks 12 (SS-12) is a brief olfactory screening test assessing odor identification ability using 12 pen-like odor pens.
Total scores range from 0 to 12, based on the number of correctly identified odors.
Higher scores indicate better outcome (superior olfactory function).
It is widely used for early Parkinson's disease screening and cognitive disorder assessment.
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baseline
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REM sleep behavior disorderscreening questionnaire
Periodo de tiempo: baseline
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REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) is a 10-item self-rated scale screening for REM sleep behavior disorder, covering dream content, dream-enactment behaviors, injuries, and neurological conditions.
Total scores range from 0 to 13.
Higher scores indicate worse outcome (greater likelihood of abnormality), with scores ≥5 considered abnormal.
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baseline
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Parkinson's disease sleep scale
Periodo de tiempo: baseline
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Parkinson's Disease Sleep Scale (PDSS) is a 15-item scale assessing sleep disturbances in Parkinson's disease, covering nighttime quality, sleep onset, maintenance, limb discomfort, dreaming, hallucinations, nocturia, and daytime sleepiness.
Total scores range from 0 to 150 (0-10 per item).
Higher scores indicate better outcome (fewer or less severe sleep problems).
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baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
1 de enero de 2024
Finalización primaria (Estimado)
Finalización primaria
31 de diciembre de 2027
Finalización del estudio (Estimado)
Finalización del estudio
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
22 de diciembre de 2025
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
25 de junio de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
1 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
1 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
Última verificación
1 de diciembre de 2025
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2026KY647
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .