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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06154564
Other study ID # PAMNEU
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date May 31, 2024

Study information

Verified date February 2024
Source Charles University, Czech Republic
Contact Aleš Bartoš, M.D., Ph.D.
Phone 00420267162297
Email ales.bartos@fnkv.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Czechia Teaching Hospital Královské Vinohrady Praha

Sponsors (1)

Lead Sponsor Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Baseline ALBA 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). Established on Day 0 as a single assessment.
Primary Baseline PICNIR 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). Established on Day 0 as a single assessment.
Primary Statistical analysis of ALBA results Statistical analysis of ALBA results compared to groups determined by ICD-10 diagnosis and demographical data. The final statistical analysis will be performed through study completion, an average of 6 months.
Primary Statistical analysis of PICNIR results Statistical analysis of PICNIR results compared to groups determined by ICD-10 diagnosis and demographical data. The final statistical analysis will be performed through study completion, an average of 6 months.
Secondary Baseline FAQ-CZ 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. Established as a baseline on Day 0.
Secondary Baseline GDS-CZ 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). Established as a baseline on Day 0.
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