- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07815964
Turkish Validity and Reliability of the Parkinson's Disease Neuropsychometric Dementia Assessment Questionnaire in Individuals With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nuray Alaca Alaca, Prof. Dr
- Phone Number: 05324251290
- Email: nuraygeceralaca@gmail.com
Study Locations
-
-
Turkey
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Istanbul, Turkey, Turkey (Türkiye), +90
- Acibadem University
-
Contact:
- Nuray ALACA
- Phone Number: 05324251290
- Email: nuray.alaca@acibadem.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Parkinson's Disease
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parkinson Neuropsychometric Dementia Assessment (PANDA) Total Score
Time Frame: [Time Frame: Baseline (at the time of PANDA administration)]
|
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)]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) Total Score
Time Frame: [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)]
|
|
Mini-Mental State Examination (MMSE) Total Score
Time Frame: [Time Frame: Baseline (at the time of cognitive assessment)]
|
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)]
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-10/436
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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