- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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).
Descripción general del estudio
Estado
Descripción detallada
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 estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Eva Nike Cvikl
- Número de teléfono: +38640336780
- Correo electrónico: eva.nike.cvikl@gmail.com
Ubicaciones de estudio
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Maribor, Eslovenia, 2000
- University Medical Centre Maribor
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Contacto:
- Eva Nike Cvikl
- Número de teléfono: +38640336780
- Correo electrónico: eva.nike.cvikl@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: CROSS_SECTIONAL
Cohortes e Intervenciones
Grupo / Cohorte |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Visuospatial Task Performance
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UKCMB-PSIH-MCI-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
A decision has not yet been made about whether de-identified individual participant data from this study will be shared with other researchers.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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