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

Not Applicable

Recruiting

• Conditions: Alzheimer Dementia; Subjective Cognitive Decline
• Interventions: Diagnostic Test: Cognigram; Diagnostic Test: Subjective cognitive decline questionnaire (SCD-Q); Diagnostic Test: blood-based biomarkers

• Registration Number: NCT06191952
• Lead Sponsor: Ludwig-Maximilians - University of Munich

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2023-12-20
• Status Verified: 2024-01
• Study First Posted: 2024-01-05
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• age 65 years or older

Exclusion Criteria

• younger than 65 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCD-Q + digital cognitive testing using Cognigram	Cognigram	Participants will undergo procedure as usual with their GP, additionally they will fill out the SCD-Q and undergo cognitive testing (Cognigram)
SCD-Q + digital cognitive testing using Cognigram	Subjective cognitive decline questionnaire (SCD-Q)	Participants will undergo procedure as usual with their GP, additionally they will fill out the SCD-Q and undergo cognitive testing (Cognigram)
SCD-Q + Cognigram + blood-based biomarkers	Cognigram	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.
Subjective Cognitive Decline Questionnaire (SCD-Q)/no other procedure	Subjective cognitive decline questionnaire (SCD-Q)	Participants will undergo procedure as usual and fill out the questionnaire SCD-Q
SCD-Q + Cognigram + blood-based biomarkers	blood-based biomarkers	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.
SCD-Q + Cognigram + blood-based biomarkers	Subjective cognitive decline questionnaire (SCD-Q)	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.

Primary Outcome Measures

Name	Time	Method
Proportion of participating individuals screening positive for SCD	Baseline	The primary endpoint of this protocol is to assess the proportion of participating individuals aged 65 years or older screening positive for SCD during the intervention period who are referred to specialist evaluation, by study arm (intent to treat)

Secondary Outcome Measures

Name	Time	Method
Correlation with speech analysis and other diagnostic tests	Baseline	Correlation of ki:e SB-C global and domain cognitive scores with established AD neuropsychological tests and biomarkers (PET, cerebrospinal fluid, blood) and added value of automated speech assessment in routine cognitive assessment
Qualitative interviews	Baseline	Qualitative participant and GP interviews on perceived changes/benefits/barriers, lessons learned, etc., per study arm
Proportion of individuals with early-stage AD diagnosis	Baseline	Proportion of individuals formally diagnosed with early-stage AD in a specialist clinic, by study arm
average time to diagnosis of AD	Baseline	Average time to diagnosis of early-stage AD, by study arm

Trial Locations

Locations (1)

Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums; 🇩🇪 München, Bayern, Germany