Clinical trial NCT06191952: Davos Alzheimer's Collaborative Healthcare System Preparedness to Increase Cognitive Assessment Rates for Older Adults
Official title: Davos Alzheimer's Collaborative Healthcare System Preparedness to Increase Cognitive Assessment Rates for Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subjective Cognitive Decline
Alzheimer Dementia
Keywords: Subjective Cognitive Decline
Mild Cognitive Impairment
Community Setting
Digital Cognitive Tests
Blood Biomarker
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: ki:elements
name: Hoffmann-La Roche
name: Eisai Limited
name: Johanniter-Unfall-Hilfe e.V.
name: University of Southern California
First posted: 2024-01-05
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

* age 65 years or older

Exclusion Criteria:

* younger than 65 years

Primary outcomes:
measure: Proportion of participating individuals screening positive for SCD
timeFrame: Baseline
Secondary outcomes:
measure: Proportion of individuals with early-stage AD diagnosis
timeFrame: Baseline
measure: average time to diagnosis of AD
timeFrame: Baseline
measure: Qualitative interviews
timeFrame: Baseline
measure: Correlation with speech analysis and other diagnostic tests
timeFrame: Baseline
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
state: Bayern
Study officials:
affiliation: Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
name: Robert Perneczky, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: