German Validation Study of the Subjective Cognitive Decline Questionnaire (SCD-Q) and Its Potential Use in Large Cohorts
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- Ludwig-Maximilians - University of Munich
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Validation of the SCD-Q in the german language
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Robert Perneczky
Principal Investigator
Ludwig-Maximilians - University of Munich
Eligibility Criteria
Inclusion Criteria
- •Medical appointment for dementia diagnostics at the Alzheimer Therapie- und Forschungszentrum
- •Provision of signed, written and dated informed consent
- •Capacity to give informed consent
Exclusion Criteria
- •dementia in a very advance stage
- •Illiteracy
Outcomes
Primary Outcomes
Validation of the SCD-Q in the german language
Time Frame: Baseline
assessment of its psychometric properties, including reliability, validity, and sensitivity/specificity, when translated into German.(neuropsychological test, neurological and psychiatric examination, MRI and optional lumbar puncture), sensitivity and specifity to identify participants with probable AD, establish cut-off values of the SCD-Q; • Internal consistency of the self-rated SCD-Q (measured by Cronbach's alpha). * Test-retest reliability (correlation coefficient between repeated measures at two time points). * Construct validity (comparison with related cognitive self-assessment tools or scales). * Discriminative ability (sensitivity and specificity for distinguishing between individuals with subjective cognitive decline and those without, using ROC analysis). * Linguistic validation process (forward and backward translation, followed by expert review and pilot testing).
combination of SCD-Q and biomarkers
Time Frame: Baseline
To determine and validate appropriate cut-off values for the self-rated SCD-Q for distinguishing between individuals with and without subjective cognitive decline. • Receiver Operating Characteristic (ROC) analysis to establish sensitivity and specificity of the SCD-Q. * Optimal cut-off values derived using Youden's Index to maximize diagnostic performance. * Units of Measure: SCD-Q total score (range: 0-100).
Correlation of SCD-Q with digital cognitive tests and a shortened version of SCD-Q
Time Frame: Baseline
correlation of the SCD-Q with a digital cognitive test and shortened version of the SCD-Q.