- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07815964
Turkish Validity and Reliability of the Parkinson's Disease Neuropsychometric Dementia Assessment Questionnaire in Individuals With Parkinson's Disease
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nuray Alaca Alaca, Prof. Dr
- Numéro de téléphone: 05324251290
- E-mail: nuraygeceralaca@gmail.com
Lieux d'étude
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Turkey
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Istanbul, Turkey, Turquie (Türkiye), +90
- Acibadem University
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Contact:
- Nuray ALACA
- Numéro de téléphone: 05324251290
- E-mail: nuray.alaca@acibadem.edu.tr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
**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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
La maladie 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parkinson Neuropsychometric Dementia Assessment (PANDA) Total Score
Délai: [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)]
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) Total Score
Délai: [Time Frame: Baseline (at the time of cognitive assessment)]
|
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
Délai: [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)]
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-10/436
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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