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

Ludwig Maximilian University of Munich

Status: Enrolling

Conditions: Alzheimer Disease; Subjective Cognitive Decline

Treatments: Diagnostic Test: biomarkers; Diagnostic Test: Cognitive Failure Questionnaire (CFQ); Diagnostic Test: Cognitive Tests; Diagnostic Test: Subjective Cognitive Decline-Questionnaire (SCD-Q)

Study type: Interventional

Funder types: Other

Identifiers

NCT06711952

22-1117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Subjective Cognitive Decline Questionnaire (SCD-Q)

Other group

Description:

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.

Treatment:

Diagnostic Test: Cognitive Tests

Diagnostic Test: Subjective Cognitive Decline-Questionnaire (SCD-Q)

Diagnostic Test: Cognitive Failure Questionnaire (CFQ)

Diagnostic Test: biomarkers