Davos Alzheimer's Collaborative Healthcare System Preparedness to Increase Cognitive Assessment Rates for Older Adults
NCT ID: NCT06191952
Last Updated: 2024-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
500 participants
INTERVENTIONAL
2023-02-01
2024-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Davos Alzheimer's Collaborative Study: Sequential Administration of Digital Testing To Screen For Cognitive Impairment Followed By Blood Based Biomarkers To Assist With Timely Detection And Accurate Diagnosis Of Alzheimer's Disease
NCT05379348
Cohort Study on Cognitive Decline in Elderly
NCT07093892
Neurocognitive Assessment Platform 4 Alzheimer
NCT07272811
5-Cog 2.0: A Pragmatic Clinical Trial
NCT05515224
Advances in Telephone-based Cognitive Screening Procedures
NCT06337578
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Subjective Cognitive Decline Questionnaire (SCD-Q)/no other procedure
Participants will undergo procedure as usual and fill out the questionnaire SCD-Q
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).
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.
SCD-Q + digital cognitive testing using Cognigram
Participants will undergo procedure as usual with their GP, additionally they will fill out the SCD-Q and undergo cognitive testing (Cognigram)
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).
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.
SCD-Q + Cognigram + 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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ki:elements
UNKNOWN
Hoffmann-La Roche
INDUSTRY
Eisai Limited
INDUSTRY
Johanniter-Unfall-Hilfe e.V.
UNKNOWN
University of Southern California
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Robert Perneczky
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Perneczky, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
München, Bavaria, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22-0786
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.