Subjective Cognitive DeclineNCT06191952
Davos Alzheimer's Collaborative Healthcare System Preparedness to Increase Cognitive Assessment Rates for Older Adults
A study testing Cognigram, Subjective cognitive decline questionnaire (SCD-Q) and blood-based biomarkers in people with Subjective Cognitive Decline and Alzheimer Dementia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Decline, Alzheimer Dementia
- What is being tested?
- Cognigram, Subjective cognitive decline questionnaire (SCD-Q) and blood-based biomarkers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65 years or older
Who cannot join
- younger than 65 years
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
München, Bavaria, 80336
Robert Perneczky, Prof. Dr., +49 89 4400 55863, PSY.Alzheimerzentrum@med.uni-muenchen.de
Carolin Kurz, Dr., +4989440055863, Psy.Alzheimerzentrum@med.uni-muenchen.de
About this study
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.
Read the 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.
- Conditions
- Subjective Cognitive Decline, Alzheimer Dementia
- Being tested
- Cognigram, Subjective cognitive decline questionnaire (SCD-Q), blood-based biomarkers, ki:elements digital speech biomarker for cognition (ki:e SB-C)
- Keywords
- Subjective Cognitive Decline, Mild Cognitive Impairment, Community Setting, Digital Cognitive Tests, Blood Biomarker
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CognigramDiagnostic test
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)Diagnostic test
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 biomarkersDiagnostic test
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)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjective Cognitive Decline Questionnaire (SCD-Q)/no other procedure | Other | Participants will undergo procedure as usual and fill out the questionnaire SCD-Q Receives: Diagnostic Test: Subjective cognitive decline questionnaire (SCD-Q); Diagnostic Test: ki:elements digital speech biomarker for cognition (ki:e SB-C) |
| SCD-Q + digital cognitive testing using Cognigram | Other | Participants will undergo procedure as usual with their GP, additionally they will fill out the SCD-Q and undergo cognitive testing (Cognigram) Receives: Diagnostic Test: Cognigram; Diagnostic Test: Subjective cognitive decline questionnaire (SCD-Q); Diagnostic Test: ki:elements digital speech biomarker for cognition (ki:e SB-C) |
| SCD-Q + Cognigram + blood-based biomarkers | Other | 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. Receives: Diagnostic Test: Cognigram; Diagnostic Test: Subjective cognitive decline questionnaire (SCD-Q); Diagnostic Test: blood-based biomarkers; Diagnostic Test: ki:elements digital speech biomarker for cognition (ki:e SB-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Secondary outcomes (4)
Proportion of individuals with early-stage AD diagnosis
Proportion of individuals formally diagnosed with early-stage AD in a specialist clinic, by study arm
Measured: Baseline
average time to diagnosis of AD
Average time to diagnosis of early-stage AD, by study arm
Measured: Baseline
Qualitative interviews
Qualitative participant and GP interviews on perceived changes/benefits/barriers, lessons learned, etc., per study arm
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Feb 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- ki:elements, Hoffmann-La Roche, Eisai Limited, Johanniter-Unfall-Hilfe e.V., University of Southern California
- Responsible party
- Principal investigator, Robert Perneczky, Ludwig-Maximilians - University of Munich
- Investigators
- Robert Perneczky, Prof. Dr., Principal investigator, Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191952
- Sponsor's protocol ID
- 22-0786
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kurz C, Wusten NC, Tegethoff P, Taute M, Kehrls M, Hufnagel A, de Jonge S, Deckert A, Suchsland MZ, Konig A, Feustel E, Heindl P, Mattke S, Perneczky R. Adaptive pathways for multimodal community-based detection of cognitive impairment: the CogScreen I study. Sci Rep. 2026 Jul 23;16(1):23072. doi: 10.1038/s41598-026-61868-x.
PubMed 42486877Tegethoff P, Perneczky R, Taute M, Deckert A, Hornbecker M, Rutt S, Hufnagel A, Mattke S, Kurz C. Motivation, Worries and Digital Affinity in Cognitive Screening - Qualitative Findings From the CogScreen Study. J Geriatr Psychiatry Neurol. 2026 Feb 25:8919887261429558. doi: 10.1177/08919887261429558. Online ahead of print.
PubMed 41738969
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Davos Alzheimer's Collaborative Healthcare System Preparedness to Increase Cognitive Assessment Rates for Older Adults
- ClinicalTrials.gov ID
- NCT06191952
- Acronym / sponsor ID
- 22-0786
- Conditions
- Subjective Cognitive Decline, Alzheimer Dementia
- Keywords
- Subjective Cognitive Decline, Mild Cognitive Impairment, Community Setting, Digital Cognitive Tests, Blood Biomarker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- ki:elements, Hoffmann-La Roche, Eisai Limited, Johanniter-Unfall-Hilfe e.V., University of Southern California
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjective Cognitive Decline Questionnaire (SCD-Q)/no other procedure | Other | Diagnostic Test: Subjective cognitive decline questionnaire (SCD-Q), Diagnostic Test: ki:elements digital speech biomarker for cognition (ki:e SB-C)Participants will undergo procedure as usual and fill out the questionnaire SCD-Q |
| SCD-Q + digital cognitive testing using Cognigram | Other | Diagnostic Test: Cognigram, Diagnostic Test: Subjective cognitive decline questionnaire (SCD-Q), Diagnostic Test: ki:elements digital speech biomarker for cognition (ki:e SB-C)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 | Other | Diagnostic Test: Cognigram, Diagnostic Test: Subjective cognitive decline questionnaire (SCD-Q), Diagnostic Test: blood-based biomarkers, Diagnostic Test: ki:elements digital speech biomarker for cognition (ki:e SB-C)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age 65 years or older
Key exclusion criteria (1 listed)
- younger than 65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CognigramCognigram (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. | Diagnostic test | SCD-Q + Cognigram + blood-based biomarkers, SCD-Q + digital cognitive testing using Cognigram |
| 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). | Diagnostic test | SCD-Q + Cognigram + blood-based biomarkers, SCD-Q + digital cognitive testing using Cognigram, Subjective Cognitive Decline Questionnaire (SCD-Q)/no other procedure |
| blood-based biomarkersBlood 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. | Diagnostic test | SCD-Q + Cognigram + blood-based biomarkers |
| 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. | Diagnostic test | SCD-Q + Cognigram + blood-based biomarkers, SCD-Q + digital cognitive testing using Cognigram, Subjective Cognitive Decline Questionnaire (SCD-Q)/no other procedure |
Primary outcome
Proportion of participating individuals screening positive for SCD
Time frame: 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)
4 secondary outcomes
Proportion of individuals with early-stage AD diagnosis
Time frame: Baseline
average time to diagnosis of AD
Time frame: Baseline
Qualitative interviews
Time frame: Baseline
Correlation with speech analysis and other diagnostic tests
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Derived from this study: PubMed 42486877Kurz C, Wusten NC, Tegethoff P, Taute M, Kehrls M, Hufnagel A, de Jonge S, Deckert A, Suchsland MZ, Konig A, Feustel E, Heindl P, Mattke S, Perneczky R. Adaptive pathways for multimodal community-based detection of cognitive impairment: the CogScreen I study. Sci Rep. 2026 Jul 23;16(1):23072. doi: 10.1038/s41598-026-61868-x.
- Derived from this study: PubMed 41738969Tegethoff P, Perneczky R, Taute M, Deckert A, Hornbecker M, Rutt S, Hufnagel A, Mattke S, Kurz C. Motivation, Worries and Digital Affinity in Cognitive Screening - Qualitative Findings From the CogScreen Study. J Geriatr Psychiatry Neurol. 2026 Feb 25:8919887261429558. doi: 10.1177/08919887261429558. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Perneczky, Prof. Dr. principal investigator
Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognigram, Subjective cognitive decline questionnaire (SCD-Q) and blood-based biomarkers in people with Subjective Cognitive Decline and Alzheimer Dementia, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Kurz (+4989440055863, Psy.Alzheimerzentrum@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participating individuals screening positive for SCD (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06191952, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.