COGSCREEN II: Early Detection of Cognitive Impairment (COGSCREEN II)

March 7, 2026 updated by: Robert Perneczky

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • München, Germany, 80336
        • Recruiting
        • Klinik für Psychiatrie und Psychotherapie am LMU Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood-Based Biomarker Testing
Behavioral: Early Detection
Blood-based Biomarker Testing
No Intervention: No Blood-bases Biomarker Testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
(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
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
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
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
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
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
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
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Perneczky

Collaborators

Davos Alzheimer's Collaborative

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 7, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-0569_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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