Health TrialsbyHealthPanel

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

ConditionsAlzheimer DiseaseSubjective Cognitive Decline
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorLudwig-Maximilians - University of Munich

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Medical appointment for dementia diagnostics at the Alzheimer Therapie- und Forschungszentrum

Provision of signed, written and dated informed consent

Capacity to give informed consent

Disqualifiers

dementia in a very advance stage

Illiteracy

Trial design

Design model

Single group

Treatments tested in this trial

  • Subjective Cognitive Decline-Questionnaire (SCD-Q)

    Diagnostic test

    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 procedures will remain unchanged.

  • Cognitive Failure Questionnaire (CFQ)

    Diagnostic test

    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.

  • biomarkers

    Diagnostic test

    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).

  • Cognitive Tests

    Diagnostic test

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Subjective Cognitive Decline Questionnaire (SCD-Q)Other 4 interventions

Trial outcomes

Primary outcomes

1

Validation of the SCD-Q in the german language

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).

Time frame
Baseline
2

combination of SCD-Q and biomarkers

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).

Time frame
Baseline
3

Correlation of SCD-Q with digital cognitive tests and a shortened version of SCD-Q

correlation of the SCD-Q with a digital cognitive test and shortened version of the SCD-Q.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ludwig-Maximilians - University of Munich

Lead sponsor

Medotrax UG

Collaborator

Source ClinicalTrials.gov
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