Davos Alzheimer's Collaborative Healthcare System Preparedness to Increase Cognitive Assessment Rates for Older Adults

Ludwig Maximilian University of Munich

Status: Enrolling

Conditions: Alzheimer Dementia; Subjective Cognitive Decline

Treatments: Diagnostic Test: Cognigram; Diagnostic Test: Subjective cognitive decline questionnaire (SCD-Q); Diagnostic Test: blood-based biomarkers; Diagnostic Test: ki:elements digital speech biomarker for cognition (ki:e SB-C)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06191952

22-0786

Details and patient eligibility

About

In this study the investigators explore a pragmatic strategy to increase cognitive screening rates in the community. The investigators will compare the monetary value of different combinations of SCD questionnaires, digital cognitive tests, and blood Alzheimer's Disease (AD) biomarkers to identify the best approach for primary care settings.

Full description

The investigators aim to perform a cluster-randomized study, exploring the effectiveness, efficiency, and acceptability of a pragmatic strategy to increase cognitive screening rates in the community. Participants will be older adults attending social and cultural centers in the greater Munich area. The investigators will compare the monetary value of different combinations of SCD questionnaires, digital cognitive tests, and blood AD biomarkers to identify the best approach for primary care settings. As secondary aims, qualitative interviews will be conducted with general practitioners (GPs) and their patients to explore the acceptability of the proposed new screening strategy; furthermore, the diagnostic utility of an artificial intelligence-based automated analysis of speech will be assessed. The initiative will not only generate novel insights into the optimal approach for large-scale cognitive screening in the general population, but also contribute to an urgently required cultural change in Germany, resulting in a sustainable solution for effective and efficient early recognition and prevention of dementia.

Enrollment: 500 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 65 years or older

Exclusion criteria

• younger than 65 years

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 3 patient groups

Subjective Cognitive Decline Questionnaire (SCD-Q)/no other procedure

Other group

Description:

Participants will undergo procedure as usual and fill out the questionnaire SCD-Q

Treatment:

Diagnostic Test: Subjective cognitive decline questionnaire (SCD-Q)

Diagnostic Test: ki:elements digital speech biomarker for cognition (ki:e SB-C)

SCD-Q + digital cognitive testing using Cognigram

Other group

Description:

Participants will undergo procedure as usual with their GP, additionally they will fill out the SCD-Q and undergo cognitive testing (Cognigram)

Treatment:

Diagnostic Test: Cognigram

Diagnostic Test: Subjective cognitive decline questionnaire (SCD-Q)

Diagnostic Test: ki:elements digital speech biomarker for cognition (ki:e SB-C)

SCD-Q + Cognigram + blood-based biomarkers

Other group

Description:

Participants will undergo procedure as usual with their GP, additionally they will fill out the SCD-Q and undergo cognitive testing (Cognigram). The blood-based biomarkers will be determined.

Treatment:

Diagnostic Test: Cognigram

Diagnostic Test: Subjective cognitive decline questionnaire (SCD-Q)

Diagnostic Test: ki:elements digital speech biomarker for cognition (ki:e SB-C)

Diagnostic Test: blood-based biomarkers