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Identificación de biomarcadores de diagnóstico en las lágrimas de pacientes con enfermedad de Alzheimer: el estudio piloto COG-EYE (COG-EYE)

4 de noviembre de 2026 actualizado por: University Hospital, Tours

Identification De Biomarqueurs Diagnostiques Dans Les Larmes De Patients Atteints De Maladie D'Alzheimer: L'étude Pilote COG-EYE

The diagnosis of Alzheimer's disease (AD) relies on the detection of protein biomarkers, particularly in cerebrospinal fluid (e.g., Aβ and phosphorylated Tau) or through brain imaging. The invasive nature of lumbar puncture and the numerous contraindications have driven the search for early and reliable diagnostic biomarkers for AD.

Human tears are an accessible biological fluid that has proven relevant in the biomarker search strategy for both ophthalmological and systemic diseases, especially neurodegenerative conditions. Advances in methods for low-volume analysis have facilitated the identification of tear biomarkers. Total tau has been reported as elevated in the tears of patients with AD compared to controls (n=65). Additionally, metabo-lipidomic analyses offer several advantages (accessibility, non-invasiveness, reproducibility) and also appear promising as a diagnostic tool for systemic and neurodegenerative diseases, such as amyotrophic lateral sclerosis. This supports the relevance of comparing both AD proteins biomarkers and metabo-lipidomic signatures in the tears of patients with AD (Mild Cognitive Impairement (MCI) and dementia) with healthy controls.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

90

Fase

  • No aplica

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

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Francia
    • France
      • Tours, France, Francia, 37044
        • Reclutamiento
        • CHRU de Tours
        • Investigador principal:
          • Victoire LEROY, MD
        • Contacto:
        • Contacto:
          • Coralie TAILLEBUIS
          • Número de teléfono: +332 47 47 39 09
          • Correo electrónico: cpcq@chu-tours.fr

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

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age ≥18 years
  • Participant affiliated in French Social Security scheme
  • Informed and written consent from the participant

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Participant under judicial protection measures
  • Participant under guardianship or curatorship
  • Contraindications to participation in the research:

Other neurodegenerative disease Any eye drops or treatment that may interfere with tear production Occasional or permanent contact lens use within the last 3 months Eye surgery ≤3 months Any ocular pathology other than refractive errors, oculomotor disorders, amblyopia Any general pathology other than AD with ocular implications

-Inability to perform tear collection

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

  • Propósito principal: Diagnóstico
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Patients with AD dementia

Patient ≥ 18 years old with AD at a major stage according to the 2018 NIA-AA criteria (dementia)
Otro: Basal tear collection for the analysis of metabo-lipidomic profiles and concentrations of protein biomarkers (Tau, phosphorylated Tau, Aβ 1-40, and Aβ 1-42)

Collection of a tear volume of (i) 2 x 5µL using glass microcapillary tubes and (ii) 12µL using Schirmer strips after the instillation of anesthetic eye drops for metabo-lipidomic analysis and multiplexing of protein markers
Comparador activo: Patients with AD Mild Cognitive Impaiment (MCI)

Patient ≥ 18 years old with AD at a minor stage according to the 2018 NIA-AA criteria (Mild Cognitive Impairment)
Otro: Basal tear collection for the analysis of metabo-lipidomic profiles and concentrations of protein biomarkers (Tau, phosphorylated Tau, Aβ 1-40, and Aβ 1-42)

Collection of a tear volume of (i) 2 x 5µL using glass microcapillary tubes and (ii) 12µL using Schirmer strips after the instillation of anesthetic eye drops for metabo-lipidomic analysis and multiplexing of protein markers

Otro: Collection of a blood sample (5 mL) for blood biomarkers analysis

Collection of a blood sample (5 mL) for blood biomarkers analysis.
Comparador falso: Healthy controls

Participants ≥ 18 years old with no known central neurological pathology, no cognitive decline, and matched by age (± 2 years) and sex with a patient from AD-MCI group
Otro: Basal tear collection for the analysis of metabo-lipidomic profiles and concentrations of protein biomarkers (Tau, phosphorylated Tau, Aβ 1-40, and Aβ 1-42)

Collection of a tear volume of (i) 2 x 5µL using glass microcapillary tubes and (ii) 12µL using Schirmer strips after the instillation of anesthetic eye drops for metabo-lipidomic analysis and multiplexing of protein markers

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers
Periodo de tiempo: At inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
At inclusion
Concentration of phosphorylated Tau proteins in basal tears of patients with AD vs healthy volunteers
Periodo de tiempo: At inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
At inclusion
Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD vs healthy volunteers
Periodo de tiempo: At inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
At inclusion
Concentration of Amyloid β 1-42 in basal tears of patients with AD vs healthy volunteers
Periodo de tiempo: At inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
At inclusion
Lipids in basal tears of patients with AD vs healthy volunteers
Periodo de tiempo: At inclusion

Collection of tears (5μL) using a glass micropipette without local anaesthetic. Lipids in tears of patients with AD vs healthy volunteers
At inclusion
Metabolites in basal tears of patients with AD vs healthy volunteers
Periodo de tiempo: At inclusion

Collection of tears (5μL) using a glass micropipette without local anaesthetic. Metabolites in tears of patients with AD vs healthy volunteers
At inclusion

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Concentration of total Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Periodo de tiempo: At inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
At inclusion
Concentration of phosphylated Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Periodo de tiempo: A inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
A inclusion
Concentration of Amyloid β 1-40 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Periodo de tiempo: A inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
A inclusion
Concentration of Amyloid β 1-42 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Periodo de tiempo: A inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
A inclusion
Lipids in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Periodo de tiempo: At inclusion

Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of lipids in basal tears using liquid chromatography-mass spectrometry.
At inclusion
Metabolites in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Periodo de tiempo: At inclusion

Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of metabolites in basal tears using liquid chromatography-mass spectrometry.
At inclusion
Concentration of total Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
Periodo de tiempo: At inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
At inclusion
Concentration of phosphorylated Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
Periodo de tiempo: At inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
At inclusion
Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
Periodo de tiempo: At inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
At inclusion
Concentration of Amyloid β 1-42 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
Periodo de tiempo: At inclusion

12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest
At inclusion
Lipids in basal tears of patients with AD-dementia vs patients with AD-MCI
Periodo de tiempo: At inclusion

Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of lipids in basal tears using liquid chromatography-mass spectrometry.
At inclusion
Metabolites in basal tears of patients with AD-dementia vs patients with AD-MCI
Periodo de tiempo: At inclusion

Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of metabolites in basal tears using liquid chromatography-mass spectrometry.
At inclusion

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University Hospital, Tours

Investigadores

  • Director de estudio: Victoire LEROY, MD, CHRU de Tours

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)

9 de julio de 2025

Finalización primaria (Estimado)

1 de julio de 2027

Finalización del estudio (Estimado)

1 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

16 de octubre de 2024

Primero enviado que cumplió con los criterios de control de calidad

24 de octubre de 2024

Publicado por primera vez (Actual)

28 de octubre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • DR240140

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Qualified researchers may obtain access to all deidentified data in COG-EYE on a substantial request.

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. .

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