German Validation Study of the Subjective Cognitive Decline Questionnaire (SCD-Q)

Официальное название

German Validation Study of the Subjective Cognitive Decline Questionnaire (SCD-Q) and Its Potential Use in Large Cohorts

Обзор

The SCD-Q (Subjective Cognitive Decline-Questionnaire) is an established instrument to quantify self-perceived cognitive decline. Both self- and informant-rated versions of the SCD-Q are available. However, the SCD-Q has not been validated in the German language yet. Hence, the investigators aim to validate the self-reported SCD-Q in a clinical sample in Germany.

Подробное описание

The SCD-Q is a well-established screening instrument to quantify perceived subjective cognitive decline. In addition to self-perceived cognitive complaints, a 24-item questionnaire for informants is part of the SCD-Q. It demonstrates high sensitivity and lower specificity for detecting dementia and early cognitive changes associated with dementia. However, the questionnaire has not been translated into German or validated. Plasma biomarkers for amyloid and tau pathology, as well as for neurodegeneration and astrocytic activation, have been developed and show promising sensitivity and specificity for detecting Alzheimer's disease (AD). A relevant proportion of biomarker-positive patients does not convert to mild cognitive impairment or Alzheimer's disease dementia during the disease course. Currently, the predictive value of blood biomarkers remains to be clarified, particularly in conjunction with SCD. This study aims to validate the SCD-Q in German and analyze possible connections with biomarkers and (digital) cognitive tests. Follow-up visits are planned.

Вмешательства

• Диагностический тест Subjective Cognitive Decline-Questionnaire (SCD-Q)
  The SCD-Q is an established instrument to quantify self-perceived cognitive decline. In addition to the self-perceived cognitive complaints, a 24 items questionnaire of informants is part of SCD-Q. The self-reported SCD-Q will be included in the standard health questionnaire that all patients of the memory clinic of the LMU Department of Psychiatry and Psychotherapy are required to complete before the examination date. The health questionnaire will be sent per mail. All routine clinical procedur
• Диагностический тест Cognitive Failure Questionnaire (CFQ)
  The Cognitive Failure Questionnaire (CFQ) is a questionnaire for measuring self-reported subjective failures in cognition, memory and motor functions in everyday life. The German CFQ consists of 32 items related to everyday possibilities of error, whose frequency in the last six months is to be estimated by means of a five-point rating scale.
• Диагностический тест biomarkers
  Blood plasma and serum samples will be collected by the project staff according to standard operating procedures used at LMU Munich and subsequently processed and measured at the Department of Psychiatry and Psychotherapy to quantify the blood-based biomarkers for AD using Elecsys immunoassays running on a Cobas e402 analyzer. Only available clinical and biomarker data will be used (Routine cerebrospinal fluid biomarkers, routine imaging biomarkers).
• Диагностический тест Cognitive Tests
  The investigators plan to examine the patients´ visuospatial performance on site with a digital clock-drawing test, which has been validated in large community-based studies. The Functional Activities Questionnaire (FAQ) shall be filled out by an informant. FAQ is a reliable and valid measure of activities of daily living. The results of the routine neuropsychological tests (Consortium to Establish a Registry for AD, Mini-Mental-State Examination) will be used in the analysis.

Первичные конечные точки

• Validation of the SCD-Q in the german language [Срок оценки: Baseline]
• combination of SCD-Q and biomarkers [Срок оценки: Baseline]
• Correlation of SCD-Q with digital cognitive tests and a shortened version of SCD-Q [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Medical appointment for dementia diagnostics at the Alzheimer Therapie- und Forschungszentrum
• Provision of signed, written and dated informed consent
• Capacity to give informed consent

Критерии исключения

• dementia in a very advance stage
• Illiteracy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Германия · 1 центр

• Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums — München

Идентификаторы

NCT: NCT06711952 · 22-1117

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗