German Validation Study of the Subjective Cognitive Decline Questionnaire (SCD-Q)
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable alzheimer-disease
Started Feb 2023
Typical duration for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2023
CompletedFirst Submitted
Initial submission to the registry
December 21, 2023
CompletedFirst Posted
Study publicly available on registry
December 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedMay 29, 2025
May 1, 2025
2.6 years
December 21, 2023
May 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
Baseline
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).
Baseline
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.
Baseline
Study Arms (1)
Subjective Cognitive Decline Questionnaire (SCD-Q)
OTHERParticipants receive treatment as usual (appointment in the memory clinic, LMU) and will additionally fill out the questionnaires. A digital cognitive test will be performed.
Interventions
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.
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.
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).
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.
Eligibility Criteria
You may qualify if:
- Medical appointment for dementia diagnostics at the Alzheimer Therapie- und Forschungszentrum
- Provision of signed, written and dated informed consent
- Capacity to give informed consent
You may not qualify if:
- dementia in a very advance stage
- Illiteracy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ludwig-Maximilians - University of Munichlead
- Medotrax UGcollaborator
Study Sites (1)
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
München, Bavaria, 80336, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Perneczky, Prof. Dr.
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 21, 2023
First Posted
December 2, 2024
Study Start
February 1, 2023
Primary Completion
August 31, 2025
Study Completion
August 31, 2025
Last Updated
May 29, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share