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Identificação de biomarcadores de diagnóstico nas lágrimas de pacientes com doença de Alzheimer: o estudo piloto COG-EYE (COG-EYE)

4 de novembro de 2026 atualizado por: University Hospital, Tours

Identificação De Biomarcadores Diagnósticos Dans Les Larmes De Pacientes 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

90

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • França
    • France
      • Tours, France, França, 37044
        • Recrutamento
        • CHRU de Tours
        • Investigador principal:
          • Victoire LEROY, MD
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Patients with AD dementia

Patient ≥ 18 years old with AD at a major stage according to the 2018 NIA-AA criteria (dementia)
Outro: 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 Ativo: 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)
Outro: 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

Outro: 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
Outro: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Concentration of total Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Tours

Investigadores

  • Diretor de estudo: Victoire LEROY, MD, CHRU de Tours

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

9 de julho de 2025

Conclusão Primária (Estimado)

1 de julho de 2027

Conclusão do estudo (Estimado)

1 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

16 de outubro de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de outubro de 2024

Primeira postagem (Real)

28 de outubro de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • DR240140

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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