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COGSCREEN II: Early Detection of Cognitive Impairment

NCT07466394 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-03-12

No results posted yet for this study

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). 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)

Interventions

BEHAVIORAL

Early Detection

Blood-based Biomarker Testing

Sponsors & Collaborators

  • Davos Alzheimer's Collaborative

    collaborator UNKNOWN

  • Robert Perneczky

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07466394 on ClinicalTrials.gov