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

NCT ID: NCT06711952

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Alzheimer Disease Subjective Cognitive Decline

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Subjective Cognitive Decline Questionnaire (SCD-Q)

Participants receive treatment as usual (appointment in the memory clinic, LMU) and will additionally fill out the questionnaires. A digital cognitive test will be performed.

Group Type OTHER

Subjective Cognitive Decline-Questionnaire (SCD-Q)

Intervention Type 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)

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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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 procedures will remain unchanged.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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).

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medotrax UG

UNKNOWN

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Robert Perneczky

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Perneczky, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums

Locations

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Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums

München, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Carolin Kurz, Dr.

Role: CONTACT

+4989440055863

Facility Contacts

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Robert Perneczky, Prof. Dr.

Role: primary

+49 89 4400 55863

Carolin Kurz, Dr.

Role: backup

+4989440055863

Other Identifiers

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22-1117

Identifier Type: -

Identifier Source: org_study_id

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