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- Ensaio Clínico NCT07931586
Mild Cognitive Impairment in Older Adults With and Without Depressive Symptom
Factors Differentiating Older Adults With Mild Cognitive Impairment and Depressive Symptoms From Those With Mild Cognitive Impairment Without Depressive Symptoms
This study will compare adults aged 65 years or older who have mild cognitive impairment, with and without depressive symptoms. The researchers plan to participants at University Medical Centre Maribor, with two equally sized groups. They will compare outcomes in several different cognitive domains (visuospatial abilities, emotional modulation, social cognition) and in DNA methylation of relevant regions (for BDNF, COMT, and SLC6A4 gene promoters).
Visão geral do estudo
Status
Descrição detalhada
This cross-sectional observational study will examine cognitive and epigenetic differences between older adults with mild cognitive impairment who have depressive symptoms and those who do not. Potential participants will be identified through the outpatient psychogeriatric, psychiatric, and neurology clinics and the inpatient geriatric psychiatry units at University Medical Centre Maribor. Participants will be aged 65 years or older, have cognitive screening results consistent with mild cognitive impairment, and provide written informed consent. The planned sample will include two equally sized groups of participants.
Participants will be classified according to the presence or absence of depressive symptoms at the initial assessment. Depressive symptoms will be reassessed early in the study to confirm group classification. Participants will receive the same standard of diagnostic assessment and treatment as patients who do not take part in the study.
The study will compare performance on tasks assessing visuospatial abilities, emotional modulation abilities and social cognition. The investigators hypothesize that participants with depressive symptoms will perform better on the visuospatial task and less well on the emotional capture and social cognition tasks than participants without depressive symptoms. Blood samples will be collected to compare DNA methylation in the promoter regions of BDNF, COMT, and SLC6A4 between the two groups.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Eva Nike Cvikl
- Número de telefone: +38640336780
- E-mail: eva.nike.cvikl@gmail.com
Locais de estudo
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Maribor, Eslovênia, 2000
- University Medical Centre Maribor
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Contato:
- Eva Nike Cvikl
- Número de telefone: +38640336780
- E-mail: eva.nike.cvikl@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
The study population will consist of adults aged 65 years or older with cognitive screening results consistent with mild cognitive impairment. Potential participants will be identified at University Medical Centre Maribor through the outpatient psychogeriatric, psychiatric, and neurology clinics and the inpatient geriatric psychiatry units. The planned sample includes equal numbers of participants with depressive symptoms without depressive symptoms.
Descrição
Inclusion Criteria:
- Age 65 years or older.
- Receiving outpatient or inpatient psychiatric care with a working diagnosis of a mood, anxiety, or cognitive disorder.
- Cognitive screening results consistent with mild cognitive impairment.
- Written informed consent to participate in the study.
Exclusion Criteria:
- Established diagnosis of Alzheimer's disease or another specific form of dementia.
- Established diagnosis of another specific neurological or neurodegenerative disease.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: CASE_CONTROL
- Perspectivas de Tempo: CROSS_SECTIONAL
Coortes e Intervenções
Grupo / Coorte |
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Mild Cognitive Impairment With Depressive Symptoms
Adults aged 65 years or older with mild cognitive impairment and depressive symptoms, as determined by the study's depression assessment. |
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Mild Cognitive Impairment Without Depressive Symptoms
Adults aged 65 years or older with mild cognitive impairment without depressive symptoms, as determined by the study's depression assessment. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Visuospatial Task Performance
Prazo: At the baseline study visit.
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Visuospatial performance will be measured using computer guided cognitive task (n-back). Values will be compared between participants with mild cognitive impairment with and without depressive symptoms. |
At the baseline study visit.
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Emotional Capture Task Performance
Prazo: At the baseline study visit.
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Emotional capture will be assessed using the computer guided Emotional Capture Task. Values will be compared between participants with mild cognitive impairment with and without depressive symptoms. |
At the baseline study visit.
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Social Cognition Performance on the Faux Pas Test
Prazo: At the baseline study visit.
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Social cognition will be assessed using the Faux Pas Test. Scores will be compared between participants with mild cognitive impairment with and without depressive symptoms. |
At the baseline study visit.
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Regional DNA Methylation (BDNF, COMT and SLC6A4 promoter gene regions)
Prazo: At the baseline study visit.
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DNA methylation will be measured in target regions using DNA obtained from blood samples. Results will be compared between participants with mild cognitive impairment with and without depressive symptoms. |
At the baseline study visit.
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UKCMB-PSIH-MCI-2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
A decision has not yet been made about whether de-identified individual participant data from this study will be shared with other researchers.
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