Clinical trial NCT06154564: PAMNEU - Memory in Neurology
Official title: PAMNEU: Easy Detection of Memory Disorders Using Very Short ALBA and PICNIR Tests in Neurological Outpatient Clinics in the Czech Republic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Impairment
Keywords: Cognitive Impairment
Outpatient Neurologic Service
Population Distribution
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population is intended to be comprised of persons (50yrs+) living in the geographical area of the Czech Republic undergoing treatment at an outpatient neurologic office for a diagnosis defined in ICD-10 (excluding mental retardation). The probability sample will be created by a random selection of persons undergoing their regular outpatient neurologic checkups.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Baseline ALBA
timeFrame: Established on Day 0 as a single assessment.
measure: Baseline PICNIR
timeFrame: Established on Day 0 as a single assessment.
measure: Statistical analysis of ALBA results
timeFrame: The final statistical analysis will be performed through study completion, an average of 6 months.
measure: Statistical analysis of PICNIR results
timeFrame: The final statistical analysis will be performed through study completion, an average of 6 months.
Secondary outcomes:
measure: Baseline FAQ-CZ
timeFrame: Established as a baseline on Day 0.
measure: Baseline GDS-CZ
timeFrame: Established as a baseline on Day 0.
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Teaching Hospital Královské Vinohrady
Study officials:
affiliation: Charles University, Czech Republic
name: Aleš Bartoš, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: