PAMNEU - Memory in Neurology

Cognitive Impairment Clinical Trial

Official title:

PAMNEU: Easy Detection of Memory Disorders Using Very Short ALBA and PICNIR Tests in Neurological Outpatient Clinics in the Czech Republic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06154564
• Other study ID #: PAMNEU
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

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.