- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06154564
PAMNEU - Memory in Neurology
PAMNEU: Easy Detection of Memory Disorders Using Very Short ALBA and PICNIR Tests in Neurological Outpatient Clinics in the Czech Republic
Memory in Neurology project (PAMNEU) aims to map the distribution and severity of cognitive impairment in patients of outpatient neurologic offices across the geographical area of the Czech Republic. 1000 patients in 50 neurologic offices will undergo cognitive tests (ALBA and PICNIR) and psychometric scales (FAQ-CZ and GDS-CZ) to asses their functional state and depressive symptoms.
The trial's primary goal is to assess the distribution of cognitive impairment among diagnostic groups in neurologic care according to the ICD-10. Additionally, the feasibility of ALBA and PICNIR methods to uncover previously undiagnosed cognitive impairments will be evaluated.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Praha, Czechia, 10000
- Teaching Hospital Královské Vinohrady
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Dispensarization of at least six months in an outpatient neurologic office with an ICD-10 diagnosis
- Age>=50
- Permanent residency in the geographical area of the Czech Republic
Exclusion Criteria:
- Diagnosis of mental retardation (F70-F79) according to ICD-10
- Refusal to sign the informed consent and consent with GDPR
- Uncorrected visual impairment
- Uncorrected auditory impairment
- Impairment of hand movement preventing the patient from filling in the questionnaires.
- Inability to participate in the project
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Observed group
No intervention will be administered on behalf of the project.
The participants will be tested using ALBA and PICNIR (non-invasive) cognitive tests, and further FAQ-CZ and GDS-CZ questionnaires will be administered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Baseline ALBA
Time Frame: Established on Day 0 as a single assessment.
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Amnesia Light and Brief Assessment (ALBA) test is an innovative method to assess cognitive functions quickly.
The cognitive performance is scaled as an overall score between 0-12 (a lower value denotes a more severe cognitive impairment).
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Established on Day 0 as a single assessment.
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Baseline PICNIR
Time Frame: Established on Day 0 as a single assessment.
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Picture Naming and Immediate Recall test (PICNIR) is an innovative test method to assess cognitive functions quickly.
The cognitive performance is scaled as an overall score between 0-20 (a lower value denotes a more severe cognitive impairment).
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Established on Day 0 as a single assessment.
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Statistical analysis of ALBA results
Time Frame: The final statistical analysis will be performed through study completion, an average of 6 months.
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Statistical analysis of ALBA results compared to groups determined by ICD-10 diagnosis and demographical data.
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The final statistical analysis will be performed through study completion, an average of 6 months.
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Statistical analysis of PICNIR results
Time Frame: The final statistical analysis will be performed through study completion, an average of 6 months.
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Statistical analysis of PICNIR results compared to groups determined by ICD-10 diagnosis and demographical data.
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The final statistical analysis will be performed through study completion, an average of 6 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Baseline GDS-CZ
Time Frame: Established as a baseline on Day 0.
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The Geriatric Depression Scale - Czech version (GDS-CZ) is a standardized questionnaire administered to assess depressive symptoms, particularly in the elderly population.
Fifteen items are scaled between 0-1 to reach the overall score between 0-15 (a higher value denotes a higher level of depressive symptoms).
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Established as a baseline on Day 0.
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Baseline FAQ-CZ
Time Frame: Established as a baseline on Day 0.
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Functional Activities Questionnaire - Czech version (FAQ-CZ) is a standardized questionnaire administered to assess a patient´s functional state regarding daily activities.
Ten items of daily functioning are scaled between 0-3 (a higher value denotes a higher dependency) to reach the overall score between 0-30 (a higher value denotes a higher dependency).
This version of the scale will be used for participants´ self-evaluation.
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Established as a baseline on Day 0.
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Collaborators and Investigators
Investigators
- Principal Investigator: Aleš Bartoš, M.D., Ph.D., Charles University, Czech Republic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAMNEU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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