- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07815964
Turkish Validity and Reliability of the Parkinson's Disease Neuropsychometric Dementia Assessment Questionnaire in Individuals With Parkinson's Disease
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nuray Alaca Alaca, Prof. Dr
- Número de teléfono: 05324251290
- Correo electrónico: nuraygeceralaca@gmail.com
Ubicaciones de estudio
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Turkey
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Istanbul, Turkey, Turquía (Türkiye), +90
- Acibadem University
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Contacto:
- Nuray ALACA
- Número de teléfono: 05324251290
- Correo electrónico: nuray.alaca@acibadem.edu.tr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
**Inclusion Criteria:**
- Clinical diagnosis of Parkinson's disease
- Hoehn and Yahr stage 1-3
- Age between 40 and 85 years
- Mini-Mental State Examination score ≥ 24
- Sufficient cognitive and communication ability to complete the assessments
- Attendance at the Movement Disorders Outpatient Clinic of the Neurology Department
- Willingness to participate in the study and provide written informed consent
**Exclusion Criteria:**
- Presence of a major psychiatric disorder, such as major depressive disorder or a psychotic disorder
- Diagnosis of advanced dementia
- Presence of an uncontrolled systemic chronic disease, such as uncontrolled diabetes mellitus or hypertension
- Presence of a severe cardiovascular or respiratory condition
- Presence of an additional orthopedic or neurological condition that may affect assessment performance
- Severe visual or hearing impairment that may interfere with the assessments
- Inability to cooperate adequately during the assessments
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Enfermedad de Parkinson
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Participants will complete the Turkish version of the Parkinson Neuropsychometric Dementia Assessment (PANDA) as part of the psychometric evaluation process.
The PANDA will be administered according to standardized instructions to assess cognitive performance in individuals with Parkinson's disease.
To evaluate test-retest reliability, the Turkish PANDA will be re-administered to a subgroup of participants after a predefined interval under similar conditions.
No therapeutic intervention will be provided as part of this methodological validation study.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Parkinson Neuropsychometric Dementia Assessment (PANDA) Total Score
Periodo de tiempo: [Time Frame: Baseline (at the time of PANDA administration)]
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Cognitive performance will be assessed using the Turkish version of the Parkinson's Neuropsychometric Dementia Assessment (PANDA) in individuals with Parkinson's disease. The PANDA is a brief cognitive screening instrument specifically developed for Parkinson's disease and includes tasks assessing learning and memory, verbal fluency, visuospatial processing, working memory, and delayed recall. The PANDA total score ranges from 0 to 30, with higher scores indicating better cognitive performance. The psychometric properties of the Turkish version, including internal consistency, test-retest reliability, and construct validity, will be evaluated. |
[Time Frame: Baseline (at the time of PANDA administration)]
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Montreal Cognitive Assessment (MoCA) Total Score
Periodo de tiempo: [Time Frame: Baseline (at the time of cognitive assessment)]
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Global cognitive performance will be assessed using the Montreal Cognitive Assessment (MoCA), a widely used cognitive screening tool that evaluates multiple cognitive domains, including attention, executive functions, memory, language, visuospatial abilities, abstraction, calculation, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. MoCA scores will be used to evaluate the convergent construct validity of the Turkish version of the Parkinson Neuropsychometric Dementia Assessment (PANDA). |
[Time Frame: Baseline (at the time of cognitive assessment)]
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Mini-Mental State Examination (MMSE) Total Score
Periodo de tiempo: [Time Frame: Baseline (at the time of cognitive assessment)]
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General cognitive status will also be assessed using the Mini-Mental State Examination (MMSE), which evaluates orientation, registration, attention and calculation, recall, language, and visuospatial abilities. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. MMSE scores will be examined in relation to PANDA scores to further assess the convergent construct validity of the Turkish version of the PANDA. |
[Time Frame: Baseline (at the time of cognitive assessment)]
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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
- 2026-10/436
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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