Davos Alzheimer's Collaborative Healthcare System Preparedness to Increase Cognitive Assessment Rates for Older Adults
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2023
CompletedFirst Submitted
Initial submission to the registry
December 20, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedJanuary 11, 2024
January 1, 2024
1 year
December 20, 2023
January 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Proportion of individuals with early-stage AD diagnosis
Baseline
average time to diagnosis of AD
Baseline
Qualitative interviews
Baseline
Correlation with speech analysis and other diagnostic tests
Baseline
Study Arms (3)
Subjective Cognitive Decline Questionnaire (SCD-Q)/no other procedure
OTHERParticipants will undergo procedure as usual and fill out the questionnaire SCD-Q
SCD-Q + digital cognitive testing using Cognigram
OTHERParticipants 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
OTHERParticipants 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.
Interventions
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.
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 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.
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.
Eligibility Criteria
You may qualify if:
- age 65 years or older
You may not qualify if:
- younger than 65 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ludwig-Maximilians - University of Munichlead
- ki:elementscollaborator
- Hoffmann-La Rochecollaborator
- Eisai Limitedcollaborator
- Johanniter-Unfall-Hilfe e.V.collaborator
- University of Southern Californiacollaborator
Study Sites (1)
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
München, Bavaria, 80336, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Perneczky, Prof. Dr.
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 20, 2023
First Posted
January 5, 2024
Study Start
February 1, 2023
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
January 11, 2024
Record last verified: 2024-01