Alzheimer's Disease (AD)COGSCREEN IINCT07466394
COGSCREEN II: Early Detection of Cognitive Impairment
A study testing Early Detection in people with Alzheimer's Disease (AD), run by Robert Perneczky at 1 site in Germany.
Trial summary
While knowledge about dementia and its causes is increasing rapidly, healthcare systems remain ill-equipped to detect cognitive decline in the early stages of neurodegenerative diseases such as Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- Early Detection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female ≥ 60 years of age at the time of consent
- Able to understand and voluntarily sign an informed consent according to the judgment of the practice team
Who cannot join
- Subjects who are unable to hear or see well enough to complete the assessments
- Prior diagnosis of dementia (with or without evidence of pathology) as documented in the medical record and/or diagnosed by a physician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Psychiatrie und Psychotherapie am LMU Klinikum
München, 80336
About this study
Official title: German: COGSCREEN II: Früherkennung Kognitiver Störungen Durch Screeningverfahren Von Haus- Und Fachärzten Bei Senioren in Deutschland English: COGSCREEN II: Early Detection of Cognitive Impairment Through Screening Procedures by General Practitioners and Specialists in Older Adults in Germany (DAC AccDx Munich Site)
While knowledge about dementia and its causes is increasing rapidly, healthcare systems remain ill-equipped to detect cognitive decline in the early stages of neurodegenerative diseases such as Alzheimer's disease (AD). However, improving the early identification of AD in the population is a prerequisite for dementia prevention and providing future disease-modifying treatments for individuals most likely to benefit. Subjective cognitive deficits (SCD) and mild cognitive impairment (MCI) may indicate prodromal AD, even in the absence of functional impairment; in conjunction with an AD-typical biomarker profile (such as abnormal protein markers in the cerebrospinal fluid, CSF), the risk of further cognitive decline increases significantly. Offering cognitive screening to individuals with SCD or MCI may therefore open a window of opportunity for early interventions.
Currently, there is no system in place for targeted, standardized identification of cases with minimal cognitive decline in Germany or worldwide, hindering efforts to detect neurodegenerative and other causes of cognitive impairment in large segments of the population. The lack of a robust approach for detecting early changes with acceptable accuracy outside of specialist clinics results in disappointingly low diagnostic rates. This is despite evidence showing that structured case finding programs can significantly improve the early detection of cognitive decline.
This project will build on an existing network of general practitioners (GPs) and specialists in private practice (neurologists, psychiatrist and geriatricians). The investigator's efforts will aim to strengthen and expand this network, resulting in a larger pool of doctors in the community who have specialized knowledge and a strong commitment to the care of people with dementia. Over the course of the project, the investigators will introduce participating physicians to proprietary digital cognitive tests and blood-based biomarkers (provided by Roche). Building on the success of the ongoing COGSCREEN project, which deploys a community-based recruitment strategy (project number 22-0786), this initiative will equip the Munich healthcare system with the necessary tools to effectively identify individuals most likely to benefit from upcoming disease-modifying treatments for AD. This will serve as a template for the implementation of a precision medicine approach to early diagnosis of AD in Germany and beyond.
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- Early Detection
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early DetectionBehavioural
Blood-based Biomarker Testing
| Study group | Role | What they receive |
|---|---|---|
| Blood-Based Biomarker Testing | Experimental | Not described Receives: Behavioral: Early Detection |
| No Blood-bases Biomarker Testing | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Alzheimer's Disease Diagnosis Supported by Blood Biomarker Evidence
Proportion of participants diagnosed with Alzheimer's disease whose diagnosis is supported by pathological blood-based biomarker results according to predefined laboratory cut-off values. The outcome will be reported as the percentage of total Alzheimer's disease diagnoses that include biomarker confirmation.
Measured: through study completion, an average of 2 year
Secondary outcomes (7)
(Number of) clinician-reported deviations from the standard diagnostic workflow after implementation of Blood Biomarker testing
Measured: through study completion, an average of 2 year
Mean direct diagnostic costs per participant during the diagnostic workup
Measured: through study completion, an average of 2 year
Proportion of correctly classified cases for detection of early Alzheimer's disease using screening modalities
Measured: through study completion, an average of 2 year
Physician acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire
Measured: through study completion, an average of 2 year
Participant acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire
Measured: Through study completion, an average of 2 year
Changes in Clinical Management Following Implementation of the Screening Model
Measured: through study completion, an average of 2 year
Diagnostic Performance and User Acceptance of the BrainChex Digital Cognitive Test Battery
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Jun 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies 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
- Model description
- Cluster-randomized controlled parallel-group interventional study
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Perneczky
- Sponsor type
- University, hospital or other
- Collaborators
- Davos Alzheimer's Collaborative
- Responsible party
- Sponsor-investigator, Robert Perneczky, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466394
- Sponsor's protocol ID
- 24-0569_1
- Acronym
- COGSCREEN II
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German: COGSCREEN II: Früherkennung Kognitiver Störungen Durch Screeningverfahren Von Haus- Und Fachärzten Bei Senioren in Deutschland English: COGSCREEN II: Early Detection of Cognitive Impairment Through Screening Procedures by General Practitioners and Specialists in Older Adults in Germany (DAC AccDx Munich Site)
- ClinicalTrials.gov ID
- NCT07466394
- Acronym / sponsor ID
- COGSCREEN II / 24-0569_1
- Conditions
- Alzheimer's Disease (AD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Robert PerneczkyUniversity, hospital or other
- Collaborators
- Davos Alzheimer's Collaborative
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 12 Mar 2026 (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.
While knowledge about dementia and its causes is increasing rapidly, healthcare systems remain ill-equipped to detect cognitive decline in the early stages of neurodegenerative diseases such as Alzheimer's disease (AD). However, improving the early identification of AD in the population is a prerequisite for dementia prevention and providing future disease-modifying treatments for individuals most likely to benefit. Subjective cognitive deficits (SCD) and mild cognitive impairment (MCI) may indicate prodromal AD, even in the absence of functional impairment; in conjunction with an AD-typical biomarker profile (such as abnormal protein markers in the cerebrospinal fluid, CSF), the risk of further cognitive decline increases significantly. Offering cognitive screening to individuals with SCD or MCI may therefore open a window of opportunity for early interventions.
Currently, there is no system in place for targeted, standardized identification of cases with minimal cognitive decline in Germany or worldwide, hindering efforts to detect neurodegenerative and other causes of cognitive impairment in large segments of the population. The lack of a robust approach for detecting early changes with acceptable accuracy outside of specialist clinics results in disappointingly low diagnostic rates. This is despite evidence showing that structured case finding programs can significantly improve the early detection of cognitive decline.
This project will build on an existing network of general practitioners (GPs) and specialists in private practice (neurologists, psychiatrist and geriatricians). The investigator's efforts will aim to strengthen and expand this network, resulting in a larger pool of doctors in the community who have specialized knowledge and a strong commitment to the care of people with dementia. Over the course of the project, the investigators will introduce participating physicians to proprietary digital cognitive tests and blood-based biomarkers (provided by Roche). Building on the success of the ongoing COGSCREEN project, which deploys a community-based recruitment strategy (project number 22-0786), this initiative will equip the Munich healthcare system with the necessary tools to effectively identify individuals most likely to benefit from upcoming disease-modifying treatments for AD. This will serve as a template for the implementation of a precision medicine approach to early diagnosis of AD in Germany and beyond.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled parallel-group interventional study
| Arm | Type | Receives |
|---|---|---|
| Blood-Based Biomarker Testing | Experimental | Behavioral: Early Detection |
| No Blood-bases Biomarker Testing | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female ≥ 60 years of age at the time of consent
- Able to understand and voluntarily sign an informed consent according to the judgment of the practice team
Key exclusion criteria (2 listed)
- Subjects who are unable to hear or see well enough to complete the assessments
- Prior diagnosis of dementia (with or without evidence of pathology) as documented in the medical record and/or diagnosed by a physician
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 |
|---|---|---|
| Early DetectionBlood-based Biomarker Testing | Behavioural | Blood-Based Biomarker Testing |
Primary outcome
Percentage of Participants With Alzheimer's Disease Diagnosis Supported by Blood Biomarker Evidence
Time frame: through study completion, an average of 2 year
Proportion of participants diagnosed with Alzheimer's disease whose diagnosis is supported by pathological blood-based biomarker results according to predefined laboratory cut-off values. The outcome will be reported as the percentage of total Alzheimer's disease diagnoses that include biomarker confirmation.
7 secondary outcomes
(Number of) clinician-reported deviations from the standard diagnostic workflow after implementation of Blood Biomarker testing
Time frame: through study completion, an average of 2 year
Mean direct diagnostic costs per participant during the diagnostic workup
Time frame: through study completion, an average of 2 year
Proportion of correctly classified cases for detection of early Alzheimer's disease using screening modalities
Time frame: through study completion, an average of 2 year
Physician acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire
Time frame: through study completion, an average of 2 year
Participant acceptance for blood-based Alzheimer's disease screening modalities as measured by a qualitative questionnaire
Time frame: Through study completion, an average of 2 year
Changes in Clinical Management Following Implementation of the Screening Model
Time frame: through study completion, an average of 2 year
Diagnostic Performance and User Acceptance of the BrainChex Digital Cognitive Test Battery
Time frame: through study completion, an average of 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Detection in people with Alzheimer's Disease (AD), run by Robert Perneczky 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. Robert Perneczky (+89440055772, robert.perneczky@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Alzheimer's Disease Diagnosis Supported by Blood Biomarker Evidence (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.