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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 50 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Alzheimer Disease, Subjective Cognitive Decline

Being tested

Subjective Cognitive Decline-Questionnaire (SCD-Q), Cognitive Failure Questionnaire (CFQ), biomarkers, Cognitive Tests

Keywords

Alzheimer's Disease, Subjective Cognitive Decline, German Validation

Medical subject headings

Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 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.

• biomarkersDiagnostic 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 TestsDiagnostic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).

   Measured: 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).

   Measured: 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.

   Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted2 Dec 2024
2. Study start1 Feb 2023
3. Primary completion31 Aug 2025 (estimated)
4. Study completion31 Aug 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.