COGSCREEN II: Early Detection of Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorRobert Perneczky

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Early Detection

    Behavioral

    Blood-based Biomarker Testing

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Blood-Based Biomarker TestingExperimental treatment 1 intervention
Group B: No Blood-bases Biomarker TestingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
through study completion, an average of 2 year

Secondary outcomes

1

(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
2

Mean direct diagnostic costs per participant during the diagnostic workup

Time frame
through study completion, an average of 2 year
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Robert Perneczky

Lead sponsor

Ludwig-Maximilians - University of Munich

Sponsor institution

Davos Alzheimer's Collaborative

Collaborator