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临床试验/NCT06154564
NCT06154564进行中(未招募)不适用

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 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
600
试验地点
1
主要终点
Baseline ALBA

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Baseline ALBA

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

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

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tadeáš Mareš

Consultation-liaison psychiatrist

Charles University, Czech Republic

研究点 (1)

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