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Clinical Trials/NCT06154564
NCT06154564Active, not recruitingNot Applicable

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

Charles University, Czech Republic1 site in 1 country600 target enrollmentStarted: November 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
600
Locations
1
Primary Endpoint
Baseline ALBA

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Prospective

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Dispensarization of at least six months in an outpatient neurologic office with an ICD-10 diagnosis
  • 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

Outcomes

Primary Outcomes

Baseline ALBA

Time Frame: Established on Day 0 as a single assessment.

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).

Baseline PICNIR

Time Frame: Established on Day 0 as a single assessment.

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).

Statistical analysis of ALBA results

Time Frame: The final statistical analysis will be performed through study completion, an average of 6 months.

Statistical analysis of ALBA results compared to groups determined by ICD-10 diagnosis and demographical data.

Statistical analysis of PICNIR results

Time Frame: The final statistical analysis will be performed through study completion, an average of 6 months.

Statistical analysis of PICNIR results compared to groups determined by ICD-10 diagnosis and demographical data.

Secondary Outcomes

  • Baseline GDS-CZ(Established as a baseline on Day 0.)
  • Baseline FAQ-CZ(Established as a baseline on Day 0.)

Investigators

Sponsor
Charles University, Czech Republic
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tadeáš Mareš

Consultation-liaison psychiatrist

Charles University, Czech Republic

Study Sites (1)

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