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

Alzheimer Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191952
• Other study ID #: 22-0786
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2024
• Source: Ludwig-Maximilians - University of Munich
• Contact: Dr. Kurz
• Phone: +4989440055863
• Email: Psy.Alzheimerzentrum[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• age 65 years or older

Exclusion Criteria:

• younger than 65 years

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Cognitive Dysfunction
• Subjective Cognitive Decline

Intervention

Diagnostic Test:
• Cognigram
Cognigram (previously known as the Cogstate Brief Battery) is a brief, computer-administered cognitive test battery requiring about 20-25 minutes for administration, consisting of four cognitive tasks to measure psychomotor function, attention, working memory, and learning and memory. Eisai owns the commercial rights for Cognigram and has kindly agreed to offer the required licenses for the present project free of charge. Digital cognitive testing will take place in the respective social and care centers on a tablet which is not connected to the internet. Testing will be performed pseudonymized and data from the cognitive tests will be downloaded regularly by the study team and added to the database at LMU hospital.
• Subjective cognitive decline questionnaire (SCD-Q)
The SCD-Q is a validated questionnaire assessing the presence of subjective cognitive deterioration in abilities such as memory, attention, language, and executive function. The scale includes 24 dichotomous questions (yes/no), evaluating decline in daily life during the last two years. The SCD-Q score ranges from 0 to 24, with higher scores indicating greater perceived cognitive change (cut-off classified as SCD equal or greater as 7).
• blood-based 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. All test results (including the respective cut-off measurements for normal vs abnormal) will be forwarded directly to the participants' GPs. No further explanations and instructions will be provided to avoid any unwanted bias, and participants will only be informed about their results by their doctors. Roche has kindly offered to provide blood biomarker assays free of charge for the present project.
• ki:elements digital speech biomarker for cognition (ki:e SB-C)
The ki:elements digital speech biomarker for cognition (ki:e SB-C) can be collected remotely in fully automated telephone visits, taking 15 minutes to complete based on three specific assessments measuring learning and memory, processing speed, executive function, and language capabilities. The ki:e SB-C uses artificial intelligence and automatic speech analysis to process and transcribe speech, followed by an extraction of relevant features, combined into four subdomain and one global cognition score.

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums	München	Bayern

Sponsors (6)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Eisai Limited, Hoffmann-La Roche, Johanniter-Unfall-Hilfe e.V., ki:elements, University of Southern California

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participating individuals screening positive for SCD	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)	Baseline
Secondary	Proportion of individuals with early-stage AD diagnosis	Proportion of individuals formally diagnosed with early-stage AD in a specialist clinic, by study arm	Baseline
Secondary	average time to diagnosis of AD	Average time to diagnosis of early-stage AD, by study arm	Baseline
Secondary	Qualitative interviews	Qualitative participant and GP interviews on perceived changes/benefits/barriers, lessons learned, etc., per study arm	Baseline
Secondary	Correlation with speech analysis and other diagnostic tests	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	Baseline